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FDA 510(k)

MODEL BERUAFON T85 & T95

K-Number: K821447 · 1982-06-09

ApplicantBeruafon, Inc.
Decision Date1982-06-09
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL BERUAFON T85 & T95 is the device name listed in this FDA 510(k) record. The listed applicant is Beruafon, Inc.. It received FDA 510(k) clearance on 1982-06-09 under 510(k) number K821447. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL BERUAFON T85 & T95?

MODEL BERUAFON T85 & T95 is a medical device that received FDA 510(k) clearance on 1982-06-09. The listed applicant is Beruafon, Inc.. The 510(k) number is K821447.

When did MODEL BERUAFON T85 & T95 receive FDA 510(k) clearance?

MODEL BERUAFON T85 & T95 received FDA 510(k) clearance on 1982-06-09, under 510(k) number K821447.

Who is the listed applicant for MODEL BERUAFON T85 & T95?

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

What is the FDA product code for MODEL BERUAFON T85 & T95?

The FDA product code for MODEL BERUAFON T85 & T95 is ESD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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