FDA 510(k)

ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M

K-Number: K071080 · 2007-08-31

Decision Date2007-08-31

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M is the device name listed in this FDA 510(k) record. The listed applicant is E Surgical, LLC. It received FDA 510(k) clearance on 2007-08-31 under 510(k) number K071080. 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 ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M?

ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M is a medical device that received FDA 510(k) clearance on 2007-08-31. The listed applicant is E Surgical, LLC. The 510(k) number is K071080.

When did ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M receive FDA 510(k) clearance?

ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M received FDA 510(k) clearance on 2007-08-31, under 510(k) number K071080.

Who is the listed applicant for ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M?

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

What is the FDA product code for ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M?

The FDA product code for ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M 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.