FDA.reportPublic FDA data

SpiroSphere

Primary DI
04057155000665
Brand
SpiroSphere
Company
eResearchTechnology GmbH
Model
SpiroSphere ECG CT
Device description
Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
Published
2024-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTYCalculator, Predicted Values, Pulmonary Function
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTYCalculator, Predicted Values, Pulmonary FunctionAnesthesiology2
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223629000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223629000SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbH2024-05-28BTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057155000665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057155000665040571550006654057155000665

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+499305720989CustomerCare@clario.com
+1 908 595 2020CustomerCare@clario.com

Regulatory Flags#

DUNS number
341625331
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04057155000924SpiroWaySpiroWay2026-08-14
04057155000948ERT PTERT PT2025-08-11
04057155000955ERT PTERT PT2025-08-11
04057155000825SpiroSphereSpiroSphere Main Unit7074072024-12-03
04057155000801SpiroWaySpiroWay2024-07-22
04057155000580SpiroSphereSpiroSphere ECG2024-07-22
04057155000597SpiroSphereCardioSphere2024-07-22
04057155000672SpiroSphereCardioSphere CT2024-07-22
04057155000689SpiroSphereSpiroSphere Standard ECG2024-07-22
04057155000696SpiroSphereCardioSphere Standard2024-07-22
04057155000795iSpiro Ultrasonic SensoriSpiro Ultrasonic Sensor2024-07-22
04057155000818SpiroWaySpiroWay2024-07-22
04057155000177Asthma Monitor AM1+AM1+2016-07-15
04057155000412ERT PTERT PT2019-02-25
04057155000771SpiroSphereSpiroSphere Main Unit7074062022-12-19
04057155000788SpiroSphereSpiroSphere CT1513132022-12-19
04057155000337RotationsflowgeberRotationsflowgeber2019-07-22
04057155000719SpiroSphereSpiroSphere Main Unit2021-02-18
04057155000726SpiroSphereSpiroSphere CT2021-02-18
04057155000757SpiroSphereSpiroSphere2021-02-18

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Primary DI, Brand, Company table
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04719872982296QT ECGQt Medical, Inc.DPS2026-10-28
04719872982302QT ECGQt Medical, Inc.DPS2026-10-28
08800159500060S-Patch CardioAIWellysis Corp.DPS2026-10-27
00860011800613CardioTagCARDIOSENSE, INC.DPS2026-10-14
00195278840202MACGe Medical Systems Information Technologies, Inc.DPS2026-10-13
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDPS2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDPS2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDPS2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDPS2026-10-04
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00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DPS2026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DPS2026-10-01
00810016252207SW Ascent 1.3.1MEDICAL GRAPHICS CORPORATIONBTY2026-08-27
06944413835153Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
00884838096738Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
00884838096745Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
06944413844919SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
06944413847422SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
00850048674028HeartBeam ECG SystemHeartBeam, Inc.DPS2026-07-16
00810209880057CORE 500 Digital Stethoscope - Navy Blue EarpieceEko Health, Inc.DPS2026-06-12
00810209880064CORE 500 Digital Stethoscope - Military Green EarpieceEko Health, Inc.DPS2026-06-12
00810209880071CORE 500 Digital Stethoscope - Navy Blue BundleEko Health, Inc.DPS2026-06-12
00810209880088CORE 500 Digital Stethoscope - Military Green BundleEko Health, Inc.DPS2026-06-12
00810016252269SW ASCENT 2.4.0 DOWNLOADMEDICAL GRAPHICS CORPORATIONBTY2026-06-10
00810016252313SW Ascent 2.5 DownloadMEDICAL GRAPHICS CORPORATIONBTY2026-06-10
00732094354959Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-06-09