The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Synectics Liberty Sys Compris Digitrapper Mk Ii Mo.
Device ID | K853648 |
510k Number | K853648 |
Device Name: | SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO |
Classification | Electrode, Ph, Stomach |
Applicant | SYNECTICS-DANTEC 333 N. MICHIGAN AVE. #2315 Chicago, IL 60601 |
Contact | Aners Essen-moller |
Correspondent | Aners Essen-moller SYNECTICS-DANTEC 333 N. MICHIGAN AVE. #2315 Chicago, IL 60601 |
Product Code | FFT |
CFR Regulation Number | 876.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-03 |
Decision Date | 1985-11-18 |