FDA 510(k)

PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50

K-Number: K092028 · 2010-02-17

ApplicantPhilips Medizin Systeme Boeblingen GmbH

Decision Date2010-02-17

Product CodeHGM

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 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 2010-02-17 under 510(k) number K092028. 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 AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50?

PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 is a medical device that received FDA 510(k) clearance on 2010-02-17. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K092028.

When did PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 receive FDA 510(k) clearance?

PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 received FDA 510(k) clearance on 2010-02-17, under 510(k) number K092028.

Who is the listed applicant for PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50?

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 AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50?

The FDA product code for PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 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.