FDA 510(k)

HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING

K-Number: K970130 · 1997-03-28

Decision Date1997-03-28

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING is the device name listed in this FDA 510(k) record. The listed applicant is Medtrex, Inc.. It received FDA 510(k) clearance on 1997-03-28 under 510(k) number K970130. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING?

HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is Medtrex, Inc.. The 510(k) number is K970130.

When did HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING receive FDA 510(k) clearance?

HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING received FDA 510(k) clearance on 1997-03-28, under 510(k) number K970130.

Who is the listed applicant for HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING?

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

What is the FDA product code for HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING?

The FDA product code for HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING is GEI.

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Official Source

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