The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for The M100 Air/oxygen Mixer.
| Device ID | K860373 |
| 510k Number | K860373 |
| Device Name: | THE M100 AIR/OXYGEN MIXER |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST., BLDG. N Costa Mesa, CA 92627 |
| Contact | Doug Domurat |
| Correspondent | Doug Domurat NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST., BLDG. N Costa Mesa, CA 92627 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-03 |
| Decision Date | 1986-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521650169 | K860373 | 000 |
| 10884521542334 | K860373 | 000 |