510(k) K822812
- Device
- YSI MODEL 23L LACTATE ANALYZER
- Applicant
- YELLOW SPRINGS INSTRUMENT CO., INC.
- 510(k) number
- K822812
- Product code
- HHP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-12-13
- Date received
- 1982-09-20
- Regulation
- 884.4900
- Classification name
- Table, Obstetrical, Manual (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3043654660
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HHP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K963505 | TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM | Tenet Medical Engineering | 1997-02-14 |
Legacy Summary#
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FDA Review#
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