Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is B-Temia, Inc.. It received FDA 510(k) clearance on 2020-09-09 under 510(k) 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. The listed applicant is B-Temia, Inc.. The 510(k) number is K201539.

When did Keeogo Dermoskeleton System receive FDA 510(k) clearance?

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

Who is the listed applicant for Keeogo Dermoskeleton System?

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

What is the FDA product code for Keeogo Dermoskeleton System?

The FDA product code for Keeogo Dermoskeleton System is PHL.

Related Devices (Code: PHL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260381EveWandercraft SASK250904Atalante XWandercraft SASK241822ReWalk® 7 Personal Exoskeleton (50-20-0005)Rewalk Robotics Ltd. Dba LifewardK233695Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc.K232077Atalante XWandercraft SASK221696ReWalk P6.0Re Walk Robotics , Ltd.

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.

↑