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FDA 510(k)

BILIBLANKET PLUS PHOTOTHERAPY SYSTEM

K-Number: K934946 · 1994-07-05

ApplicantBoc Health Care, Inc.
Decision Date1994-07-05
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BILIBLANKET PLUS PHOTOTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Boc Health Care, Inc.. It received FDA 510(k) clearance on 1994-07-05 under 510(k) number K934946. 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 PLUS PHOTOTHERAPY SYSTEM?

BILIBLANKET PLUS PHOTOTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-05. The listed applicant is Boc Health Care, Inc.. The 510(k) number is K934946.

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

BILIBLANKET PLUS PHOTOTHERAPY SYSTEM received FDA 510(k) clearance on 1994-07-05, under 510(k) number K934946.

Who is the listed applicant for BILIBLANKET PLUS PHOTOTHERAPY SYSTEM?

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

What is the FDA product code for BILIBLANKET PLUS PHOTOTHERAPY SYSTEM?

The FDA product code for BILIBLANKET PLUS PHOTOTHERAPY SYSTEM is LBI.

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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.

K251308SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical ProductsK243372BiliWrapGerium Medical, Ltd.K210289Infant Phototherapy EquipmentBistos Co., Ltd.K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) LimitedK190899bili-hutLittle Sparrows Technologies, Inc.K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated

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.

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