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FDA 510(k)

GEM

K-Number: K213385 · 2022-07-01

ApplicantObsidio, Inc.
Decision Date2022-07-01
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GEM is a medical device manufactured by Obsidio, Inc.. It received FDA 510(k) clearance on 2022-07-01 under approval number K213385. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM?

GEM is a medical device that received FDA 510(k) clearance on 2022-07-01. It is manufactured by Obsidio, Inc.. The 510(k) number is K213385.

When was GEM approved by the FDA?

GEM received FDA 510(k) clearance on 2022-07-01, under approval number K213385.

What company makes GEM?

GEM is manufactured by Obsidio, Inc..

What is the FDA product code for GEM?

The FDA product code for GEM is KRD.

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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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