FDA 510(k)

MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30

K-Number: K062137 · 2006-08-24

ApplicantPhilips Medizin Systeme Boeblingen GmbH

Decision Date2006-08-24

Product CodeHGM

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 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 2006-08-24 under 510(k) number K062137. 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 MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30?

MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 is a medical device that received FDA 510(k) clearance on 2006-08-24. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K062137.

When did MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 receive FDA 510(k) clearance?

MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 received FDA 510(k) clearance on 2006-08-24, under 510(k) number K062137.

Who is the listed applicant for MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30?

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 MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30?

The FDA product code for MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 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.