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FDA 510(k)

BioStamp nPoint

K-Number: K173510 · 2018-05-08

ApplicantMc10, Inc.
Decision Date2018-05-08
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BioStamp nPoint is the device name listed in this FDA 510(k) record. The listed applicant is Mc10, Inc.. It received FDA 510(k) clearance on 2018-05-08 under 510(k) number K173510. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioStamp nPoint?

BioStamp nPoint is a medical device that received FDA 510(k) clearance on 2018-05-08. The listed applicant is Mc10, Inc.. The 510(k) number is K173510.

When did BioStamp nPoint receive FDA 510(k) clearance?

BioStamp nPoint received FDA 510(k) clearance on 2018-05-08, under 510(k) number K173510.

Who is the listed applicant for BioStamp nPoint?

The FDA 510(k) record lists Mc10, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioStamp nPoint?

The FDA product code for BioStamp nPoint is DRG.

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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.

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