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FDA 510(k)

BELZER-MPS

K-Number: K972066 · 1997-11-26

ApplicantTrans-Med Corp.
Decision Date1997-11-26
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BELZER-MPS is the device name listed in this FDA 510(k) record. The listed applicant is Trans-Med Corp.. It received FDA 510(k) clearance on 1997-11-26 under 510(k) number K972066. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELZER-MPS?

BELZER-MPS is a medical device that received FDA 510(k) clearance on 1997-11-26. The listed applicant is Trans-Med Corp.. The 510(k) number is K972066.

When did BELZER-MPS receive FDA 510(k) clearance?

BELZER-MPS received FDA 510(k) clearance on 1997-11-26, under 510(k) number K972066.

Who is the listed applicant for BELZER-MPS?

The FDA 510(k) record lists Trans-Med Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BELZER-MPS?

The FDA product code for BELZER-MPS is KDN.

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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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