The following data is part of a premarket notification filed by Yellow Springs Instrument Co., Inc. with the FDA for Ysi Model 23l Lactate Analyzer.
| Device ID | K822812 |
| 510k Number | K822812 |
| Device Name: | YSI MODEL 23L LACTATE ANALYZER |
| Classification | Table, Obstetrical, Manual (and Accessories) |
| Applicant | YELLOW SPRINGS INSTRUMENT CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HHP |
| CFR Regulation Number | 884.4900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-20 |
| Decision Date | 1982-12-13 |