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FDA 510(k)

ELECTROCARE

K-Number: K942631 · 1995-10-27

ApplicantWaco Corp.
Decision Date1995-10-27
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTROCARE is the device name listed in this FDA 510(k) record. The listed applicant is Waco Corp.. It received FDA 510(k) clearance on 1995-10-27 under 510(k) number K942631. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROCARE?

ELECTROCARE is a medical device that received FDA 510(k) clearance on 1995-10-27. The listed applicant is Waco Corp.. The 510(k) number is K942631.

When did ELECTROCARE receive FDA 510(k) clearance?

ELECTROCARE received FDA 510(k) clearance on 1995-10-27, under 510(k) number K942631.

Who is the listed applicant for ELECTROCARE?

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

What is the FDA product code for ELECTROCARE?

The FDA product code for ELECTROCARE is GZJ.

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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.

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