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FDA 510(k)

CarpX

K-Number: K200559 · 2020-04-20

ApplicantPavmed, Inc.
Decision Date2020-04-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CarpX is a medical device manufactured by Pavmed, Inc.. It received FDA 510(k) clearance on 2020-04-20 under approval number K200559. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CarpX?

CarpX is a medical device that received FDA 510(k) clearance on 2020-04-20. It is manufactured by Pavmed, Inc.. The 510(k) number is K200559.

When was CarpX approved by the FDA?

CarpX received FDA 510(k) clearance on 2020-04-20, under approval number K200559.

What company makes CarpX?

CarpX is manufactured by Pavmed, Inc..

What is the FDA product code for CarpX?

The FDA product code for CarpX is GEI.

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Official Source

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