The following data is part of a premarket notification filed by American Instrument Co. with the FDA for Hem-o-scan Oxygen Equil. Curve Analyzer.
| Device ID | K802379 |
| 510k Number | K802379 |
| Device Name: | HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER |
| Classification | Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical |
| Applicant | AMERICAN INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LCH |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-30 |
| Decision Date | 1980-10-31 |