NSPIRE HEALTH, INC.

Matched from indexed company URL: NSPIRE HEALTH LTD

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1722076	1000117266	NSPIRE HEALTH, INC.	1	Y	2020-04-25	1830 LEFTHAND CIR Longmont CO US 80501

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
68665	1929266291	K993199	POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER	CAF	2000-03-28
68665	1073382033	K992743	COLLINS CPL	BZG	1999-09-13
68665	1730322788	K934475	KOKO FILTER II	CAH	1993-10-21
68665	1772512726	K924343	WRIGHT POCKET PEAK FLOW METER	BZH	1993-06-16
68665	1053127908	K914272	KOKO SPIROMETER	BZG	1992-07-02
68665	1786955876	K852102	COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM	CCM	1985-07-31
68665	1691063749	K051572	KOKO LEGEND	BZG	2005-11-17
68665	1355985289	K030917	GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130	BZG	2003-05-14
68665	1424121336	K030464	GEM, MODEL 004110	BZG	2003-03-14
68665	1496216967	K013489	KP + LFM	BZH	2001-11-29
68665	1087012526	K010009	KOKO PEAK KP; KOKO PEAK KP+	BZH	2001-06-01
68665	1553478287
68665	1556232830
68665	1581761923
68665	1595155698
68665	1657550959
68665	1950179237

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
BZG	5	2005-11-17
BZH	3	2001-11-29
CAF	1	2000-03-28
CAH	1	1993-10-21
CCM	1	1985-07-31

PMN#

WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014

2009-09-21

NSPIRE HEALTH, INC.

GUDID#

nSpire Health - Spirometry and Diffusion Capacity Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusing Capacity (using ATS/ERS 10-second breath-hold or 3-Equation no breath hold methods), Single Breath Lung Volumes including SVC, Maldistribution of Ventilation, Delta N2 & Closing Volume, and optional Maximum Pressures (MIP/MEP) tests.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Legend II Spirometer (without printer)

NSPIRE HEALTH, INC.

2016-09-15

nSpire Health - KoKo Legend II Spirometer (with printer)

NSPIRE HEALTH, INC.

2016-09-15

nSpire Health - KoKo Sx 1000 spirometer and software package, fully compatible with Iris server to allow support for networked data access, patient questionnaires, workflow, and HL7 connectivity.

NSPIRE HEALTH, INC.

2017-01-24

nSpire Health - KoKo Sx 1000 spirometer and software package. The Standalone Edition is configured to operate on a single computer without access to an Iris central database.

NSPIRE HEALTH, INC.

2017-01-24

nSpire Health - Spirometry, Diffusion Capacity, Nitrogen Washout Lung Volumes and Plethysmography Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusing Capacity (using ATS/ERS 10-second breath-hold or 3-Equation no breath hold methods), Single Breath Lung Volumes including SVC, Multiple Breath Nitrogen Washout Lung Volumes, Maldistribution of Ventilation, Delta N2 & Closing Volume, Whole Body Plethysmograph for Lung Volumes, Airways Resistance & Conductance and optional Maximum Pressures (MIP/MEP) tests.

NSPIRE HEALTH, INC.

2018-12-14

nSpire Health - Spirometry, Diffusion Capacity and Plethysmography Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusing Capacity (using ATS/ERS 10-second breath-hold or 3-Equation no breath hold methods), Single Breath Lung Volumes including SVC, Maldistribution of Ventilation, Whole Body Plethysmograph for Lung Volumes, Airways Resistance & Conductance and optional Maximum Pressures (MIP/MEP) tests.

NSPIRE HEALTH, INC.

2018-12-14

nSpire Health - Spirometry, Diffusion Capacity and Nitrogen Washout Lung Volumes Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusing Capacity (using ATS/ERS 10-second breath-hold or 3-Equation no breath hold methods), Single Breath Lung Volumes including SVC, Multiple Breath Nitrogen Washout Lung Volumes, Maldistribution of Ventilation, Delta N2 & Closing Volume and optional Maximum Pressures (MIP/MEP) tests.

NSPIRE HEALTH, INC.

2018-12-14

nSpire Health - Spirometry and Diffusion Capacity Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusing Capacity (using ATS/ERS 10-second breath-hold or 3-Equation no breath hold methods), Single Breath Lung Volumes including SVC, Maldistribution of Ventilation and optional Maximum Pressures (MIP/MEP) tests.

NSPIRE HEALTH, INC.

2018-12-14

nSpire Health - Wright Respirometer Mk 8

NSPIRE HEALTH LTD

2017-01-24

nSpire Health - Wright Respirometer Mk 14

NSPIRE HEALTH LTD

2017-01-24

nSpire Health - Wright Respirometer Haloscale Standard

NSPIRE HEALTH LTD

2017-01-24

nSpire Health - KoKo Filter Sample Pack for KoKo Sx, KoKo Legend, KoKo DigiDoser and KoKo Trek.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - All-digital, tempered glass and metal body plethysmograph features fail-safe automatic release of the cabin door locking mechanism, patient intercom, and motorized sensor arm, providing superior performance, patient comfort and convenience.

NSPIRE HEALTH, INC.

2017-12-28

nSpire Health - Spirometry, Diffusion Capacity, and Plethysmography Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusing Capacity (using ATS/ERS 10-second breath-hold or 3-Equation no breath hold methods), Single Breath Lung Volumes including SVC, Maldistribution of Ventilation, Delta N2 & Closing Volume, Whole Body Plethysmograph for Lung Volumes, Airways Resistance & Conductance, and optional Maximum Pressures (MIP/MEP) tests.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - Spirometry, Diffusion Capacity, and Nitrogen Washout Lung Volumes Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusing Capacity (using ATS/ERS 10-second breath-hold or 3-Equation no breath hold methods), Single Breath Lung Volumes including SVC, Multiple Breath Nitrogen Washout Lung Volumes, Maldistribution of Ventilation, Delta N2 & Closing Volume, and optional Maximum Pressures (MIP/MEP) tests.

NSPIRE HEALTH, INC.

2016-09-16

Hudson RCI - Pocket Chamber Anti-Static Valved Aerosol Holding Chamber 50-Pack.

NSPIRE HEALTH, INC.

2016-09-20

nSpire Health - KoKo Standard Pulmonary Function Filter, Blue for Ambriex.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Standard Pulmonary Function Filter, White, 30mm ID x 33.5mm OD for Jaeger and ZAN. Box of 100.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Standard Pulmonary Function Filter, White, 26.3mm ID x 30mm OD for MicroMedical, Vitalograph, Schiller, MultiSpiro/Creative Biomedics, and MIR. Box of 100.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Standard Pulmonary Function Filter, White, 30mm ID x 34mm OD for most SensorMedics models . Box of 100.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Standard Pulmonary Function Filter, White for KoKo Px, HDpft, Collins. Box of 100.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Standard Pulmonary Function Filter, White, Green, Blue, and Yellow for KoKo Sx, KoKo Legend, KoKo DigiDoser, and KoKo Trek Spirometers. Box of 100.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Standard Pulmonary Function Filter, White for KoKo Sx, KoKo Legend, KoKo DigiDoser, and KoKo Trek Spirometers. Box of 100.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Standard Pulmonary Function Filter, Blue for KoKo Sx, KoKo Legend, KoKo DigiDoser, and KoKo Trek Spirometers. Box of 100.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Elliptical Pulmonary Function Filter, White, Green, Blue, and Yellow for KoKo Sx, KoKo Legend, KoKo DigiDoser, and KoKo Trek Spirometers. Box of 100.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Elliptical Pulmonary Function Filter, White for KoKo Sx, KoKo Legend, KoKo DigiDoser, and KoKo Trek Spirometers. Box of 100.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Elliptical Pulmonary Function Filter, Blue for KoKo Sx, KoKo Legend, KoKo DigiDoser and KoKo Trek Spirometers. Box of 100.

NSPIRE HEALTH, INC.

2016-09-16

Hudson RCI - Pocket Chamber Anti-Static Valved Aerosol Holding Chamber 10-Pack.

NSPIRE HEALTH, INC.

2016-09-20

Hudson RCI - Pocket Peak Peak Flow Meter, Universal Range 50-720 LPM

NSPIRE HEALTH, INC.

2016-09-20

nSpire Health - All-digital, tempered glass and metal body plethysmograph features fail-safe automatic release of the cabin door locking mechanism, patient intercom, and motorized sensor arm, providing superior performance, patient comfort and convenience.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - Bronchial Challenge Kit, Disposable (single patient use).

NSPIRE HEALTH, INC.

2016-06-08

nSpire Health - KoKo Standard White Filter Kit with Nose Clip and Rubber Mouthpiece 30mm ID x 33.5mm OD for use with Jaeger and ZAN. Box of 50.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Standard Pulmonary Function Filter Kit, White with Cardboard Mouthpiece. 26.3mm ID x 30mm OD for use with MicroMedical, Vitalograph, Schiller, MultiSpiro/Creative Biomedics, MIR. Box of 100.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Standard White Filter Kit with Nose Clip and Rubber Mouthpiece 30mm ID x 34mm OD for use with most SensorMedics models. Box of 50.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Standard White Filter Kit with Nose Clip and Rubber Mouthpiece for use with KoKo Px, HDpft, and Collins. Box of 100.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Pulmonary Function Filter Kit, White with Rubber Mouthpiece for KoKo Px, HDpft and Collins PFT Systems.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Standard White Filter Kit with Nose Clip and Rubber Mouthpiece for use with KoKo Px, HDpft, and Collins. Box of 50.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Standard Blue Filter Kit with Nose Clip and Rubber Mouthpiece for use with KoKo Sx, KoKo Legend, KoKo Digidoser and KoKo Trek Spirometers. Box of 50.

NSPIRE HEALTH, INC.

2016-09-16

nSpire Health - KoKo Standard Blue Filter kit with Foam Nose Clips for use with KoKo, KoKo SX, Legend (I&II), KoKo DigiDoser and KoKo Trek Spirometers. Box of 100.

NSPIRE HEALTH, INC.

2016-09-16