The following data is part of a premarket notification filed by Matrix Medica, Inc. with the FDA for Nitronox(r), First Response Nitronox(tm).
| Device ID | K883833 |
| 510k Number | K883833 |
| Device Name: | NITRONOX(R), FIRST RESPONSE NITRONOX(TM) |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | MATRIX MEDICA, INC. 145 MID COUNTY DR. Orchard Park, NY |
| Contact | Wynne, P.e. |
| Correspondent | Wynne, P.e. MATRIX MEDICA, INC. 145 MID COUNTY DR. Orchard Park, NY |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-09 |
| Decision Date | 1989-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816711020363 | K883833 | 000 |