The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Zinetics Composite Sensor Probe W/internal Ref..
Device ID | K925405 |
510k Number | K925405 |
Device Name: | ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. |
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 | 1992-10-26 |
Decision Date | 1994-09-30 |