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FDA 510(k)

Keeogo Dermoskeleton System

K-Number: K201539 · 2020-09-09

ApplicantB-Temia, Inc.
Decision Date2020-09-09
Product CodePHL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Keeogo Dermoskeleton System is a medical device manufactured by B-Temia, Inc.. It received FDA 510(k) clearance on 2020-09-09 under approval number K201539. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Keeogo Dermoskeleton System?

Keeogo Dermoskeleton System is a medical device that received FDA 510(k) clearance on 2020-09-09. It is manufactured by B-Temia, Inc.. The 510(k) number is K201539.

When was Keeogo Dermoskeleton System approved by the FDA?

Keeogo Dermoskeleton System received FDA 510(k) clearance on 2020-09-09, under approval number K201539.

What company makes Keeogo Dermoskeleton System?

Keeogo Dermoskeleton System is manufactured by B-Temia, Inc..

What is the FDA product code for Keeogo Dermoskeleton System?

The FDA product code for Keeogo Dermoskeleton System is PHL.

Related Clinical Trials

Related Devices (Code: PHL)

Official Source

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