FDA 510(k)

SURGICAL STIMULATORS

K-Number: K110422 · 2011-05-26

Decision Date2011-05-26

Product CodeETN

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

SURGICAL STIMULATORS is the device name listed in this FDA 510(k) record. The listed applicant is Technomed Europe. It received FDA 510(k) clearance on 2011-05-26 under 510(k) number K110422. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL STIMULATORS?

SURGICAL STIMULATORS is a medical device that received FDA 510(k) clearance on 2011-05-26. The listed applicant is Technomed Europe. The 510(k) number is K110422.

When did SURGICAL STIMULATORS receive FDA 510(k) clearance?

SURGICAL STIMULATORS received FDA 510(k) clearance on 2011-05-26, under 510(k) number K110422.

Who is the listed applicant for SURGICAL STIMULATORS?

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

What is the FDA product code for SURGICAL STIMULATORS?

The FDA product code for SURGICAL STIMULATORS is ETN.

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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.