The following data is part of a premarket notification filed by Berchtold Holding Gmbh with the FDA for Teletom(r).
| Device ID | K921626 |
| 510k Number | K921626 |
| Device Name: | TELETOM(R) |
| Classification | Table, Operating-room, Ac-powered |
| Applicant | BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 Tuttlingen, DE D-78532 |
| Contact | Wolfram K Hill |
| Correspondent | Wolfram K Hill BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 Tuttlingen, DE D-78532 |
| Product Code | FQO |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-06 |
| Decision Date | 1992-05-05 |