The following data is part of a premarket notification filed by Sk Med with the FDA for Air Oxyge Mixer.
| Device ID | K974372 |
| 510k Number | K974372 |
| Device Name: | AIR OXYGE MIXER |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | SK MED 16000 SHERMAN WAY #224 Van Nuys, CA 91406 |
| Contact | Dipak Ghosh |
| Correspondent | Dipak Ghosh SK MED 16000 SHERMAN WAY #224 Van Nuys, CA 91406 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-20 |
| Decision Date | 1998-02-05 |
| Summary: | summary |