The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Modified Proxima Monitor/digitrapper Ed Unit.
Device ID | K902366 |
510k Number | K902366 |
Device Name: | MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT |
Classification | Electrode, Ph, Stomach |
Applicant | SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving, TX 75038 |
Contact | Anna Pettersson |
Correspondent | Anna Pettersson SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving, TX 75038 |
Product Code | FFT |
CFR Regulation Number | 876.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-16 |
Decision Date | 1990-06-08 |