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FDA 510(k)

MEDELA APGAR TIMER

K-Number: K834129 · 1984-01-10

ApplicantMedela, Inc.
Decision Date1984-01-10
Product CodeLHB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDELA APGAR TIMER is the device name listed in this FDA 510(k) record. The listed applicant is Medela, Inc.. It received FDA 510(k) clearance on 1984-01-10 under 510(k) number K834129. 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 MEDELA APGAR TIMER?

MEDELA APGAR TIMER is a medical device that received FDA 510(k) clearance on 1984-01-10. The listed applicant is Medela, Inc.. The 510(k) number is K834129.

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

MEDELA APGAR TIMER received FDA 510(k) clearance on 1984-01-10, under 510(k) number K834129.

Who is the listed applicant for MEDELA APGAR TIMER?

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

What is the FDA product code for MEDELA APGAR TIMER?

The FDA product code for MEDELA APGAR TIMER is LHB.

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Related Devices (Code: LHB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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