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FDA 510(k)

SENSOMETRICS SOFTWARE

K-Number: K101133 · 2010-11-18

ApplicantDpcom AS
Decision Date2010-11-18
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SENSOMETRICS SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Dpcom AS. It received FDA 510(k) clearance on 2010-11-18 under 510(k) number K101133. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSOMETRICS SOFTWARE?

SENSOMETRICS SOFTWARE is a medical device that received FDA 510(k) clearance on 2010-11-18. The listed applicant is Dpcom AS. The 510(k) number is K101133.

When did SENSOMETRICS SOFTWARE receive FDA 510(k) clearance?

SENSOMETRICS SOFTWARE received FDA 510(k) clearance on 2010-11-18, under 510(k) number K101133.

Who is the listed applicant for SENSOMETRICS SOFTWARE?

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

What is the FDA product code for SENSOMETRICS SOFTWARE?

The FDA product code for SENSOMETRICS SOFTWARE is GWM.

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Official Source

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