The following data is part of a premarket notification filed by Cybermed Control Systems, Inc. with the FDA for Cyberrx Model 7200.
Device ID | K934434 |
510k Number | K934434 |
Device Name: | CYBERRX MODEL 7200 |
Classification | Electrode, Ph, Stomach |
Applicant | CYBERMED CONTROL SYSTEMS, INC. 12770 HIGH BLUFF DR. SUITE 180 San Diego, CA 92130 |
Contact | Michael S Goldberg |
Correspondent | Michael S Goldberg CYBERMED CONTROL SYSTEMS, INC. 12770 HIGH BLUFF DR. SUITE 180 San Diego, CA 92130 |
Product Code | FFT |
CFR Regulation Number | 876.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-23 |
Decision Date | 1995-01-24 |