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FDA 510(k)

DISPOSABLE PATIENT RETURN ELECTRODE

K-Number: K960569 · 1996-03-11

ApplicantErbe USA, Inc.
Decision Date1996-03-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE PATIENT RETURN ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Erbe USA, Inc.. It received FDA 510(k) clearance on 1996-03-11 under 510(k) number K960569. 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 DISPOSABLE PATIENT RETURN ELECTRODE?

DISPOSABLE PATIENT RETURN ELECTRODE is a medical device that received FDA 510(k) clearance on 1996-03-11. The listed applicant is Erbe USA, Inc.. The 510(k) number is K960569.

When did DISPOSABLE PATIENT RETURN ELECTRODE receive FDA 510(k) clearance?

DISPOSABLE PATIENT RETURN ELECTRODE received FDA 510(k) clearance on 1996-03-11, under 510(k) number K960569.

Who is the listed applicant for DISPOSABLE PATIENT RETURN ELECTRODE?

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

What is the FDA product code for DISPOSABLE PATIENT RETURN ELECTRODE?

The FDA product code for DISPOSABLE PATIENT RETURN ELECTRODE 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.

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