The following data is part of a premarket notification filed by Matrx Medical, Inc. with the FDA for Matrx Mdm, Ra.
| Device ID | K945722 |
| 510k Number | K945722 |
| Device Name: | MATRX MDM, RA |
| Classification | Gas-machine, Anesthesia |
| Applicant | MATRX MEDICAL, INC. 145 MID COUNTY DR. Orchard Park, NY 14127 |
| Contact | Michael Swart |
| Correspondent | Michael Swart MATRX MEDICAL, INC. 145 MID COUNTY DR. Orchard Park, NY 14127 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-21 |
| Decision Date | 1994-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816711020677 | K945722 | 000 |
| 00816711020226 | K945722 | 000 |
| 00816711020233 | K945722 | 000 |
| 00816711020240 | K945722 | 000 |
| 00816711020257 | K945722 | 000 |
| 00816711020264 | K945722 | 000 |
| 00816711020271 | K945722 | 000 |
| 00816711020288 | K945722 | 000 |
| 00816711020660 | K945722 | 000 |
| 00816711020219 | K945722 | 000 |