FDA 510(k)

ELECTRONIC APGAR TIMER

K-Number: K811424 · 1981-07-09

ApplicantPt&E

Decision Date1981-07-09

Product CodeLHB

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ELECTRONIC APGAR TIMER is the device name listed in this FDA 510(k) record. The listed applicant is Pt&E. It received FDA 510(k) clearance on 1981-07-09 under 510(k) number K811424. The device is classified under product code LHB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRONIC APGAR TIMER?

ELECTRONIC APGAR TIMER is a medical device that received FDA 510(k) clearance on 1981-07-09. The listed applicant is Pt&E. The 510(k) number is K811424.

When did ELECTRONIC APGAR TIMER receive FDA 510(k) clearance?

ELECTRONIC APGAR TIMER received FDA 510(k) clearance on 1981-07-09, under 510(k) number K811424.

Who is the listed applicant for ELECTRONIC APGAR TIMER?

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

What is the FDA product code for ELECTRONIC APGAR TIMER?

The FDA product code for ELECTRONIC APGAR TIMER is LHB.

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Related Devices (Code: LHB)

K834129MEDELA APGAR TIMERMedela, Inc.

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.