General Purpose Combination PH Electrode

FDA 510(k) K871921 · Chemfet Corp.

Substantially Equivalent

510(k) numberK871921

Submission

Device name
General Purpose Combination PH Electrode
Applicant
Chemfet Corp.
Bellevue, WA, US
Received
May 18, 1987
Decision date
October 20, 1987
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

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More from Synectics-Dantec

510(k)DeviceDecision
K873361Life-Span CableIKD · Traditional 11/09/1987SE
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Questions and answers

When was General Purpose Combination PH Electrode cleared by the FDA?

General Purpose Combination PH Electrode (K871921) received a 510(k) decision of Substantially Equivalent on October 20, 1987, 155 days after the submission was received.

What is the product code of K871921?

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