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FDA 510(k)

POST-OP ELECTRODE (TENS ELECTRODE)

K-Number: K820082 · 1982-01-28

ApplicantConsolidated Medical Equipment, Inc.
Decision Date1982-01-28
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

POST-OP ELECTRODE (TENS ELECTRODE) is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Medical Equipment, Inc.. It received FDA 510(k) clearance on 1982-01-28 under 510(k) number K820082. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POST-OP ELECTRODE (TENS ELECTRODE)?

POST-OP ELECTRODE (TENS ELECTRODE) is a medical device that received FDA 510(k) clearance on 1982-01-28. The listed applicant is Consolidated Medical Equipment, Inc.. The 510(k) number is K820082.

When did POST-OP ELECTRODE (TENS ELECTRODE) receive FDA 510(k) clearance?

POST-OP ELECTRODE (TENS ELECTRODE) received FDA 510(k) clearance on 1982-01-28, under 510(k) number K820082.

Who is the listed applicant for POST-OP ELECTRODE (TENS ELECTRODE)?

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

What is the FDA product code for POST-OP ELECTRODE (TENS ELECTRODE)?

The FDA product code for POST-OP ELECTRODE (TENS ELECTRODE) is GXY.

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Other records listing Consolidated Medical Equipment, Inc. as applicant

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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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