510(k) K090722
- Device
- SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
- Applicant
- SHAPE MEDICAL SYSTEMS, INC
- 510(k) number
- K090722
- Product code
- BTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-03-31
- Date received
- 2009-03-19
- Regulation
- 868.1890
- Classification name
- Calculator, Predicted Values, Pulmonary Function
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- CLARENCE JOHNSON
- Address
- 1313 5th Ave. SE Suite 205 Minneapolis MN US 55414 55414
FDA Registration Numbers#
- 9680276
- 8030673
- 3016218294
- 3002808458
- 3030308442
- 2433214
- 3033959233
- 3008072932
- 3037873864
- 1000154583
- 9615102
- 3010594620
- 1314417
- 2183022
- 3008505660
- 8021084
- 2134715
- 9614485
Source Documents#
Other 510(k) Records For Product Code BTY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242809 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | 2024-10-17 |
| K223629 | SpiroSphere, SpiroSphereECG, CardioSphere | Eresearchtechnology GmbH | 2024-05-28 |
| K231561 | Pulmonary Function Tester, Model: A9 | Guangzhou Homesun Medical Technology Co., Ltd. | 2024-02-21 |
| K222982 | Virtus Metabolic Monitor | Virtus Technology Aps | 2023-06-23 |
| K221030 | Model 9100 PFT/DICO | Vitalograph Ireland, Ltd. | 2022-07-15 |
| K202754 | MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU | Eresearchtechnology GmbH | 2021-01-28 |
| K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors | Cosmed Srl | 2020-02-06 |
| K181912 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | 2019-04-12 |
| K173937 | SpiroSphere | Eresearchtechnology GmbH | 2019-02-15 |
| K161534 | EasyOne Pro Respiratory Analysis System | Ndd Medizintechnik AG | 2017-02-22 |
| K150888 | Shape-HF Cardiopulmonary Testing System | Shape Medical Systems, Inc. | 2016-01-21 |
| K122699 | SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | 2012-11-19 |
| K120635 | EASYONE PRO RESPIRATORY TESTING DEVICE | Ndd Medizitechnik AG | 2012-09-27 |
| K113813 | SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | 2012-05-10 |
| K111053 | SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | 2011-08-12 |
Legacy Summary#
summary
FDA Review#
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