The following data is part of a premarket notification filed by A2j, Inc. with the FDA for A2j Mz 44 B Type.
| Device ID | K880981 |
| 510k Number | K880981 |
| Device Name: | A2J MZ 44 B TYPE |
| Classification | Monitor, Patient Position, Light-beam |
| Applicant | A2J, INC. 10500 RICHMOND SUITE 201 Houston, TX 77042 |
| Contact | Zimmer |
| Correspondent | Zimmer A2J, INC. 10500 RICHMOND SUITE 201 Houston, TX 77042 |
| Product Code | IWE |
| CFR Regulation Number | 892.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-08 |
| Decision Date | 1988-04-22 |