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FDA 510(k)

BILIBED PHOTOTHERAPY LAMP

K-Number: K962612 · 1996-12-12

ApplicantMedela, Inc.
Decision Date1996-12-12
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BILIBED PHOTOTHERAPY LAMP is the device name listed in this FDA 510(k) record. The listed applicant is Medela, Inc.. It received FDA 510(k) clearance on 1996-12-12 under 510(k) number K962612. 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 BILIBED PHOTOTHERAPY LAMP?

BILIBED PHOTOTHERAPY LAMP is a medical device that received FDA 510(k) clearance on 1996-12-12. The listed applicant is Medela, Inc.. The 510(k) number is K962612.

When did BILIBED PHOTOTHERAPY LAMP receive FDA 510(k) clearance?

BILIBED PHOTOTHERAPY LAMP received FDA 510(k) clearance on 1996-12-12, under 510(k) number K962612.

Who is the listed applicant for BILIBED PHOTOTHERAPY LAMP?

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 BILIBED PHOTOTHERAPY LAMP?

The FDA product code for BILIBED PHOTOTHERAPY LAMP is LBI.

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Other records listing Medela, Inc. as applicant

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Related Devices (Code: LBI)

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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