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 |