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FDA 510(k)

SKIN DOSE MONITOR

K-Number: K961105 · 1996-09-05

ApplicantMcmahon Medical
Decision Date1996-09-05
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SKIN DOSE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Mcmahon Medical. It received FDA 510(k) clearance on 1996-09-05 under 510(k) number K961105. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKIN DOSE MONITOR?

SKIN DOSE MONITOR is a medical device that received FDA 510(k) clearance on 1996-09-05. The listed applicant is Mcmahon Medical. The 510(k) number is K961105.

When did SKIN DOSE MONITOR receive FDA 510(k) clearance?

SKIN DOSE MONITOR received FDA 510(k) clearance on 1996-09-05, under 510(k) number K961105.

Who is the listed applicant for SKIN DOSE MONITOR?

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

What is the FDA product code for SKIN DOSE MONITOR?

The FDA product code for SKIN DOSE MONITOR is OWB.

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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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