FDA 510(k)

LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD

K-Number: K951328 · 1995-04-25

Decision Date1995-04-25

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD is the device name listed in this FDA 510(k) record. The listed applicant is Labeltape Meditect, Inc.. It received FDA 510(k) clearance on 1995-04-25 under 510(k) number K951328. 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 LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD?

LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD is a medical device that received FDA 510(k) clearance on 1995-04-25. The listed applicant is Labeltape Meditect, Inc.. The 510(k) number is K951328.

When did LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD receive FDA 510(k) clearance?

LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD received FDA 510(k) clearance on 1995-04-25, under 510(k) number K951328.

Who is the listed applicant for LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD?

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

What is the FDA product code for LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD?

The FDA product code for LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD 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.