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FDA 510(k)

NEOBLUE COZY LED PHOTOTHERAPY SYSTEM

K-Number: K051869 · 2005-10-07

ApplicantNatus Medical, Inc.
Decision Date2005-10-07
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEOBLUE COZY LED PHOTOTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical, Inc.. It received FDA 510(k) clearance on 2005-10-07 under 510(k) number K051869. 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 NEOBLUE COZY LED PHOTOTHERAPY SYSTEM?

NEOBLUE COZY LED PHOTOTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2005-10-07. The listed applicant is Natus Medical, Inc.. The 510(k) number is K051869.

When did NEOBLUE COZY LED PHOTOTHERAPY SYSTEM receive FDA 510(k) clearance?

NEOBLUE COZY LED PHOTOTHERAPY SYSTEM received FDA 510(k) clearance on 2005-10-07, under 510(k) number K051869.

Who is the listed applicant for NEOBLUE COZY LED PHOTOTHERAPY SYSTEM?

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

What is the FDA product code for NEOBLUE COZY LED PHOTOTHERAPY SYSTEM?

The FDA product code for NEOBLUE COZY LED PHOTOTHERAPY SYSTEM is LBI.

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Other records listing Natus Medical, 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)

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

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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