The following data is part of a premarket notification filed by A2j, Inc. with the FDA for A2j Telemeter.
| Device ID | K904127 |
| 510k Number | K904127 |
| Device Name: | A2J TELEMETER |
| Classification | Monitor, Patient Position, Light-beam |
| Applicant | A2J, INC. 225 INDUSTRIAL CT. Fredericksburg, VA 22408 |
| Contact | Olivier Jacqueau |
| Correspondent | Olivier Jacqueau A2J, INC. 225 INDUSTRIAL CT. Fredericksburg, VA 22408 |
| Product Code | IWE |
| CFR Regulation Number | 892.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-29 |
| Decision Date | 1991-01-04 |