FDA 510(k)

PHILIPS OBTRACEVUE MODEL SW REV. G.00

K-Number: K100420 · 2010-07-26

ApplicantPhilips Medizin Systeme Boeblingen GmbH

Decision Date2010-07-26

Product CodeHGM

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

PHILIPS OBTRACEVUE MODEL SW REV. G.00 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2010-07-26 under 510(k) number K100420. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS OBTRACEVUE MODEL SW REV. G.00?

PHILIPS OBTRACEVUE MODEL SW REV. G.00 is a medical device that received FDA 510(k) clearance on 2010-07-26. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K100420.

When did PHILIPS OBTRACEVUE MODEL SW REV. G.00 receive FDA 510(k) clearance?

PHILIPS OBTRACEVUE MODEL SW REV. G.00 received FDA 510(k) clearance on 2010-07-26, under 510(k) number K100420.

Who is the listed applicant for PHILIPS OBTRACEVUE MODEL SW REV. G.00?

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

What is the FDA product code for PHILIPS OBTRACEVUE MODEL SW REV. G.00?

The FDA product code for PHILIPS OBTRACEVUE MODEL SW REV. G.00 is HGM.

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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.