Set -502T PH Esophageal Micro Size Electrode

FDA 510(k) K850778 · Settler Medical Electronics, Inc.

Substantially Equivalent

510(k) numberK850778

Submission

Device name
Set -502T PH Esophageal Micro Size Electrode
Applicant
Settler Medical Electronics, Inc.
Winnipeg, CA
Received
February 26, 1985
Decision date
June 13, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FFT – Electrode, Ph, Stomach
Device class
Class I (low risk)
Regulation
21 CFR 876.1400
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FFT

510(k)DeviceApplicantDecision
K102543Bravo PH Monitoring System and AccessoriesFFT · Traditional Given Imaging , Ltd.12/01/2010SE
K013951Sandhill Scientific Pediatec PH ProbeFFT · Traditional Sandhill Scientific, Inc.02/28/2002SE
K002028Bravo PH Monitoring SystemFFT · Traditional Endonetics, Inc.09/29/2000SE
K961346PH Analysis ModuleFFT · Traditional Synectics-Dantec01/29/1997SE
K950087Lot 440FFT · Traditional Medical Instruments Corporation Mic AG02/06/1996SE
K955018Trip NGS & Sigmoid Catheter Phi Slide CalculatorFFT · Traditional Instrumentarium Corp.01/30/1996SE
K945069Flexilog 2000FFT · Traditional Oakfield Instruments, Ltd.06/13/1995SE
K920849Trip Cic CatheterFFT · Traditional Tonometrics, Inc.03/17/1995SE
K934434Cyberrx Model 7200FFT · Traditional Cybermed Control Systems, Inc.01/24/1995SE
K925405Zinetics Composite Sensor Probe W/Internal Ref.FFT · Traditional Synectics-Dantec09/30/1994SE

Questions and answers

When was Set -502T PH Esophageal Micro Size Electrode cleared by the FDA?

Set -502T PH Esophageal Micro Size Electrode (K850778) received a 510(k) decision of Substantially Equivalent on June 13, 1985, 107 days after the submission was received.

What is the product code of K850778?

The FDA product code is FFT – Electrode, Ph, Stomach, a Class I (low risk) device regulated under 21 CFR 876.1400.