FDA.reportPublic FDA data

NA

Primary DI
B2075003470
Brand
NA
Company
BENSON MEDICAL INSTRUMENTS COMPANY
Model
CCS-200
Catalog number
NA
Device description
SPIROMETER
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123896000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123896000CCS-200 SPIROMETERBenson Medical Instruments Co.2013-09-10BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B2075003470PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometerA mains electricity (AC-powered) device designed to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]. It is an instrument used in a clinical setting with a mouthpiece and tube attached to a computerized unit to process the data from patient ventilatory efforts, volume and/or flow sensors, a display, and usually a graph recorder. The data are compared to standardized values or the patient's former values to help identify or evaluate chronic pulmonary disorders such as asthma, emphysema, or bronchitis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
612-827-2222TECHSUPPORT@BENSONMEDICAL.COM

Regulatory Flags#

DUNS number
957930696
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B207500326100NA500326-100500326-1002016-10-22
B207500434100NA500434-100NA2016-09-16
B2075002960NANEXTNA2016-09-16
B2075003030NACCA-200MNA2016-09-16
B2075003070NACCA-100MNA2016-09-16
B2075003220NASMART TONENA2016-09-16
B2075004420Benson Medical Instruments Co.CCF200NA2017-05-01

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