The following data is part of a premarket notification filed by Berchtold Holding Gmbh with the FDA for Teletom.
| Device ID | K940405 |
| 510k Number | K940405 |
| Device Name: | TELETOM |
| Classification | Monitor, Bed Patient |
| Applicant | BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 Tuttlingen, DE D-78532 |
| Contact | W. Hill |
| Correspondent | W. Hill BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 Tuttlingen, DE D-78532 |
| Product Code | KMI |
| CFR Regulation Number | 880.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-27 |
| Decision Date | 1994-04-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TELETOM 76628002 3161338 Live/Registered |
BERCHTOLD GMBH & CO. KG 2005-01-14 |
![]() TELETOM 73739878 1571722 Dead/Cancelled |
DELMA GMBH 1988-07-14 |