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FDA 510(k)

INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST

K-Number: K122480 · 2013-03-27

ApplicantInternational Biophysics Corporation
Decision Date2013-03-27
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST is the device name listed in this FDA 510(k) record. The listed applicant is International Biophysics Corporation. It received FDA 510(k) clearance on 2013-03-27 under 510(k) number K122480. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST?

INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST is a medical device that received FDA 510(k) clearance on 2013-03-27. The listed applicant is International Biophysics Corporation. The 510(k) number is K122480.

When did INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST receive FDA 510(k) clearance?

INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST received FDA 510(k) clearance on 2013-03-27, under 510(k) number K122480.

Who is the listed applicant for INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST?

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

What is the FDA product code for INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST?

The FDA product code for INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST is BYI.

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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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