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FDA 510(k)

BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1

K-Number: K072097 · 2007-10-30

ApplicantMedical Select, Inc.
Decision Date2007-10-30
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Select, Inc.. It received FDA 510(k) clearance on 2007-10-30 under 510(k) number K072097. 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 BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1?

BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 is a medical device that received FDA 510(k) clearance on 2007-10-30. The listed applicant is Medical Select, Inc.. The 510(k) number is K072097.

When did BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 receive FDA 510(k) clearance?

BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 received FDA 510(k) clearance on 2007-10-30, under 510(k) number K072097.

Who is the listed applicant for BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1?

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

What is the FDA product code for BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1?

The FDA product code for BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 is LBI.

Related Clinical Trials

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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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