The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Physio Gas Analyzer.
| Device ID | K843423 |
| 510k Number | K843423 |
| Device Name: | PHYSIO GAS ANALYZER |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City, UT 84119 |
| Contact | Michael N Kelly |
| Correspondent | Michael N Kelly RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City, UT 84119 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-31 |
| Decision Date | 1985-02-26 |