FDA 510(k)

MPOWER, MODEL 712 SERIES

K-Number: K022001 · 2002-07-12

Decision Date2002-07-12

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MPOWER, MODEL 712 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Positron Corp.. It received FDA 510(k) clearance on 2002-07-12 under 510(k) number K022001. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MPOWER, MODEL 712 SERIES?

MPOWER, MODEL 712 SERIES is a medical device that received FDA 510(k) clearance on 2002-07-12. The listed applicant is Positron Corp.. The 510(k) number is K022001.

When did MPOWER, MODEL 712 SERIES receive FDA 510(k) clearance?

MPOWER, MODEL 712 SERIES received FDA 510(k) clearance on 2002-07-12, under 510(k) number K022001.

Who is the listed applicant for MPOWER, MODEL 712 SERIES?

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

What is the FDA product code for MPOWER, MODEL 712 SERIES?

The FDA product code for MPOWER, MODEL 712 SERIES is KPS.

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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.