FLOSENSE, MODEL 29-8010
FDA 510(k) clearance K990962 · decided 2000-01-07
Clearance details
- K-number
- K990962
- Device name
- FLOSENSE, MODEL 29-8010
- Applicant
- Sdi Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-22
- Decision date
- 2000-01-07
- Days to decision
- 291 days
- Clearance type
- Traditional
- Product code
- JAX
- Device class
- 2
- Regulation number
- 868.2550
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Easton, MA, 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 |
|---|---|---|
| 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 |
| RESPIRATORY FLOW MODULE (K833265) | Thoratec Laboratories Corp. | 1983-11-28 |
| 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.