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FDA 510(k)

P3T ABDOMEN

K-Number: K082458 · 2008-10-17

ApplicantMedrad, Inc.
Decision Date2008-10-17
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

P3T ABDOMEN is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 2008-10-17 under 510(k) number K082458. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P3T ABDOMEN?

P3T ABDOMEN is a medical device that received FDA 510(k) clearance on 2008-10-17. The listed applicant is Medrad, Inc.. The 510(k) number is K082458.

When did P3T ABDOMEN receive FDA 510(k) clearance?

P3T ABDOMEN received FDA 510(k) clearance on 2008-10-17, under 510(k) number K082458.

Who is the listed applicant for P3T ABDOMEN?

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

What is the FDA product code for P3T ABDOMEN?

The FDA product code for P3T ABDOMEN is JAK.

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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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