Ph Analysis Module

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K961346 ↗

FDA Product Code

FFT

Device Class

Class I

Regulation

21 CFR Part 876.1400

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Digitrapper Mark Iii

  Class I

  FDA 510(k) K913387 Active Cleared 27 Dec 1991

• Synectics Ph Sys Comprising Digitrapper Mark Ii, E

  Class I

  FDA 510(k) K850361 Active Cleared 1 May 1985

• Ambul. Ph & Motility Recorder for Measure of Para.

  Class II

  FDA 510(k) K880581 Active Cleared 11 Aug 1988

• Zinetics Composite Sensor Probe W/Internal Ref.

  Class I

  FDA 510(k) K925405 Active Cleared 30 Sep 1994

• Microtrapper/Microdigitrapper, Modification

  Class II

  FDA 510(k) K905520 Active Cleared 26 Apr 1991

• Synectics Liberty System, Pc Polygraf & Polygram

  Class II

  FDA 510(k) K900494 Active Cleared 11 Jun 1990

See all devices from Synectics-Dantec →