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 |