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FDA 510(k)

SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE

K-Number: K850778 · 1985-06-13

ApplicantSettler Medical Electronics, Inc.
Decision Date1985-06-13
Product CodeFFT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Settler Medical Electronics, Inc.. It received FDA 510(k) clearance on 1985-06-13 under 510(k) number K850778. The device is classified under product code FFT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE?

SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE is a medical device that received FDA 510(k) clearance on 1985-06-13. The listed applicant is Settler Medical Electronics, Inc.. The 510(k) number is K850778.

When did SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE receive FDA 510(k) clearance?

SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE received FDA 510(k) clearance on 1985-06-13, under 510(k) number K850778.

Who is the listed applicant for SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE?

The FDA 510(k) record lists Settler Medical Electronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE?

The FDA product code for SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE is FFT.

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Related Devices (Code: FFT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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