RESPIRATORY FLOW MODULE
FDA 510(k) clearance K833265 · decided 1983-11-28
Clearance details
- K-number
- K833265
- Device name
- RESPIRATORY FLOW MODULE
- Applicant
- Thoratec Laboratories Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-21
- Decision date
- 1983-11-28
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- JAX
- Device class
- 2
- Regulation number
- 868.2550
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FLOSENSE, MODEL 29-8010 (K990962) | Sdi Diagnostics, Inc. | 2000-01-07 |
| PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS (K921178) | Medical Associated Services, Inc. | 1992-08-26 |
| SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR (K884464) | Spirometrics, Inc. | 1989-01-19 |
| PAX METER (K853085) | Peace Medical, Inc. | 1985-09-03 |
| FLO-COR I (K812825) | Biotrine Corp. | 1981-10-26 |
| RING-ORIFICE, TURBULENT FLOW PNEUMOT (K791730) | Research Development Corp. | 1979-11-16 |
| VO RESPIRATORY PNEUMOTACHOGRAPH (K770061) | Research Development Corp. | 1977-01-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S062) | Thoratec Laboratories Corp. | 2016-06-14 |
| THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S061) | Thoratec Laboratories Corp. | 2016-01-21 |
| THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S060) | Thoratec Laboratories Corp. | 2015-06-04 |
| THORATEC VENTRICULAR ASSIST DEVICE (P870072/S059) | Thoratec Laboratories Corp. | 2014-03-18 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S058) | Thoratec Laboratories Corp. | 2013-12-19 |
| THORATEC VENTRICULAR ASSIST DEVICE(VAD) (P870072/S057) | Thoratec Laboratories Corp. | 2013-12-18 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S055) | Thoratec Laboratories Corp. | 2013-12-10 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S054) | Thoratec Laboratories Corp. | 2013-10-11 |