INSPIRON PULMONARY FUNCTION ANALYZER
FDA 510(k) clearance K802920 · decided 1981-02-23
Clearance details
- K-number
- K802920
- Device name
- INSPIRON PULMONARY FUNCTION ANALYZER
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-18
- Decision date
- 1981-02-23
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- BZC
- Device class
- 2
- Regulation number
- 868.1880
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| MiniBox + (K161295) | Pulmone Advanced Medical Devices, Ltd. | 2016-10-21 |
| Vyntus / SentrySuite Product Line (K150810) | Carefusion Germany 234 GmbH | 2015-08-14 |
| VYNTUS/ SENTRYSUITE PRODUCT LINE (K133925) | Carefusion Germany 234 GmbH | 2014-08-22 |
| PULMONE MINIBOX PFT TM (K133051) | Pulmone Advanced Medical Devices, Ltd. | 2014-05-02 |
| LCI OPTION FOR INNOCOR (K102047) | Innovision A/S | 2011-11-01 |
| MASTERSCREEN & OXYCON CPX (K072323) | Viasys Healthcare GmbH | 2007-10-10 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |