FDA 510(k)

BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR

K-Number: K122278 · 2012-11-07

Decision Date2012-11-07

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2012-11-07 under 510(k) number K122278. 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 BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR?

BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR is a medical device that received FDA 510(k) clearance on 2012-11-07. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K122278.

When did BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR receive FDA 510(k) clearance?

BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR received FDA 510(k) clearance on 2012-11-07, under 510(k) number K122278.

Who is the listed applicant for BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR?

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

What is the FDA product code for BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR?

The FDA product code for BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR 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.