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FDA 510(k)

PRODIGY NPWT SYSTEM MODEL PRODIGY 800V

K-Number: K082415 · 2008-11-25

ApplicantPremco Medical Systems, Inc.
Decision Date2008-11-25
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRODIGY NPWT SYSTEM MODEL PRODIGY 800V is the device name listed in this FDA 510(k) record. The listed applicant is Premco Medical Systems, Inc.. It received FDA 510(k) clearance on 2008-11-25 under 510(k) number K082415. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRODIGY NPWT SYSTEM MODEL PRODIGY 800V?

PRODIGY NPWT SYSTEM MODEL PRODIGY 800V is a medical device that received FDA 510(k) clearance on 2008-11-25. The listed applicant is Premco Medical Systems, Inc.. The 510(k) number is K082415.

When did PRODIGY NPWT SYSTEM MODEL PRODIGY 800V receive FDA 510(k) clearance?

PRODIGY NPWT SYSTEM MODEL PRODIGY 800V received FDA 510(k) clearance on 2008-11-25, under 510(k) number K082415.

Who is the listed applicant for PRODIGY NPWT SYSTEM MODEL PRODIGY 800V?

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

What is the FDA product code for PRODIGY NPWT SYSTEM MODEL PRODIGY 800V?

The FDA product code for PRODIGY NPWT SYSTEM MODEL PRODIGY 800V is OMP.

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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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