YSI MODEL 23L LACTATE ANALYZER
FDA 510(k) clearance K822812 · decided 1982-12-13
Clearance details
- K-number
- K822812
- Device name
- YSI MODEL 23L LACTATE ANALYZER
- Applicant
- Yellow Springs Instrument Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-09-20
- Decision date
- 1982-12-13
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- HHP
- Device class
- 2
- Regulation number
- 884.4900
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Walker, MI, 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 |
|---|---|---|
| TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM (K963505) | Tenet Medical Engineering | 1997-02-14 |
Recalls involving this device
No recalls on record reference this clearance.