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FDA 510(k)

BiopSee, Mobile US

K-Number: K170841 · 2017-07-26

ApplicantMedcom GmbH
Decision Date2017-07-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BiopSee, Mobile US is a medical device manufactured by Medcom GmbH. It received FDA 510(k) clearance on 2017-07-26 under approval number K170841. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BiopSee, Mobile US?

BiopSee, Mobile US is a medical device that received FDA 510(k) clearance on 2017-07-26. It is manufactured by Medcom GmbH. The 510(k) number is K170841.

When was BiopSee, Mobile US approved by the FDA?

BiopSee, Mobile US received FDA 510(k) clearance on 2017-07-26, under approval number K170841.

What company makes BiopSee, Mobile US?

BiopSee, Mobile US is manufactured by Medcom GmbH.

What is the FDA product code for BiopSee, Mobile US?

The FDA product code for BiopSee, Mobile US is LLZ.

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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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