The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Synectics Liberty System Amplifier And Software.
Device ID | K871282 |
510k Number | K871282 |
Device Name: | SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE |
Classification | Electrode, Ph, Stomach |
Applicant | SYNECTICS-DANTEC 611 N. BROADWAY, SUITE 412 ADD INFO TO K872712 Milwaukee, WI 53202 |
Contact | Anders Essen-moller |
Correspondent | Anders Essen-moller SYNECTICS-DANTEC 611 N. BROADWAY, SUITE 412 ADD INFO TO K872712 Milwaukee, WI 53202 |
Product Code | FFT |
CFR Regulation Number | 876.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-31 |
Decision Date | 1987-06-10 |