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FDA 510(k)

AMEDA PHOTOTHERAPY LAMP FOR NEWBORN

K-Number: K834335 · 1984-04-20

ApplicantEgnell, Inc.
Decision Date1984-04-20
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMEDA PHOTOTHERAPY LAMP FOR NEWBORN is the device name listed in this FDA 510(k) record. The listed applicant is Egnell, Inc.. It received FDA 510(k) clearance on 1984-04-20 under 510(k) number K834335. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMEDA PHOTOTHERAPY LAMP FOR NEWBORN?

AMEDA PHOTOTHERAPY LAMP FOR NEWBORN is a medical device that received FDA 510(k) clearance on 1984-04-20. The listed applicant is Egnell, Inc.. The 510(k) number is K834335.

When did AMEDA PHOTOTHERAPY LAMP FOR NEWBORN receive FDA 510(k) clearance?

AMEDA PHOTOTHERAPY LAMP FOR NEWBORN received FDA 510(k) clearance on 1984-04-20, under 510(k) number K834335.

Who is the listed applicant for AMEDA PHOTOTHERAPY LAMP FOR NEWBORN?

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

What is the FDA product code for AMEDA PHOTOTHERAPY LAMP FOR NEWBORN?

The FDA product code for AMEDA PHOTOTHERAPY LAMP FOR NEWBORN is LBI.

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Other records listing Egnell, Inc. as applicant

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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Related Devices (Code: LBI)

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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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