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FDA 510(k)

BILIBLANKET PHOTOTHERAPY DEVICE

K-Number: K894129 · 1989-09-28

ApplicantOhmeda Medical
Decision Date1989-09-28
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BILIBLANKET PHOTOTHERAPY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical. It received FDA 510(k) clearance on 1989-09-28 under 510(k) number K894129. 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 BILIBLANKET PHOTOTHERAPY DEVICE?

BILIBLANKET PHOTOTHERAPY DEVICE is a medical device that received FDA 510(k) clearance on 1989-09-28. The listed applicant is Ohmeda Medical. The 510(k) number is K894129.

When did BILIBLANKET PHOTOTHERAPY DEVICE receive FDA 510(k) clearance?

BILIBLANKET PHOTOTHERAPY DEVICE received FDA 510(k) clearance on 1989-09-28, under 510(k) number K894129.

Who is the listed applicant for BILIBLANKET PHOTOTHERAPY DEVICE?

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

What is the FDA product code for BILIBLANKET PHOTOTHERAPY DEVICE?

The FDA product code for BILIBLANKET PHOTOTHERAPY DEVICE is LBI.

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Other records listing Ohmeda Medical 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)

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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