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FDA 510(k)

NATUS BLUE LIGHT PHOTOTHERAPY UNIT

K-Number: K022196 · 2002-09-19

ApplicantNatus Medical, Inc.
Decision Date2002-09-19
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NATUS BLUE LIGHT PHOTOTHERAPY UNIT 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 2002-09-19 under 510(k) number K022196. 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 NATUS BLUE LIGHT PHOTOTHERAPY UNIT?

NATUS BLUE LIGHT PHOTOTHERAPY UNIT is a medical device that received FDA 510(k) clearance on 2002-09-19. The listed applicant is Natus Medical, Inc.. The 510(k) number is K022196.

When did NATUS BLUE LIGHT PHOTOTHERAPY UNIT receive FDA 510(k) clearance?

NATUS BLUE LIGHT PHOTOTHERAPY UNIT received FDA 510(k) clearance on 2002-09-19, under 510(k) number K022196.

Who is the listed applicant for NATUS BLUE LIGHT PHOTOTHERAPY UNIT?

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 NATUS BLUE LIGHT PHOTOTHERAPY UNIT?

The FDA product code for NATUS BLUE LIGHT PHOTOTHERAPY UNIT is LBI.

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Other records listing Natus Medical, Inc. as applicant

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K093304PROTEKTOR 32K093949OLYMPIC BRAINZ MONITOR MODEL OBM70001K090019NATUS NEUROWORKS, MODEL 104196K083371NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)K073665ALGO 5 NEWBORN HEARING SCREENERK051869NEOBLUE COZY LED PHOTOTHERAPY SYSTEM

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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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