The following data is part of a premarket notification filed by F.m. Wiest Usa, Inc. with the FDA for Camsys 6300.
Device ID | K920574 |
510k Number | K920574 |
Device Name: | CAMSYS 6300 |
Classification | Cystometer, Electrical Recording |
Applicant | F.M. WIEST USA, INC. 690 KINDERKAMACK RD., 1ST FL. P.O. BOX 637 Oradell, NJ 07649 |
Contact | George Batchelor |
Correspondent | George Batchelor F.M. WIEST USA, INC. 690 KINDERKAMACK RD., 1ST FL. P.O. BOX 637 Oradell, NJ 07649 |
Product Code | EXQ |
CFR Regulation Number | 876.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-07 |
Decision Date | 1993-02-17 |