FDA 510(k)

BiopSee, Mobile US

K-Number: K170841 · 2017-07-26

Decision Date2017-07-26

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BiopSee, Mobile US is the device name listed in this FDA 510(k) record. The listed applicant is Medcom GmbH. It received FDA 510(k) clearance on 2017-07-26 under 510(k) 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. The listed applicant is Medcom GmbH. The 510(k) number is K170841.

When did BiopSee, Mobile US receive FDA 510(k) clearance?

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

Who is the listed applicant for BiopSee, Mobile US?

The FDA 510(k) record lists Medcom GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Medcom GmbH as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.