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FDA 510(k)

Neonatal Phototherapy System

K-Number: K200031 · 2020-10-05

ApplicantAvalon Biomedical (Shenzhen) Limited
Decision Date2020-10-05
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Neonatal Phototherapy System is the device name listed in this FDA 510(k) record. The listed applicant is Avalon Biomedical (Shenzhen) Limited. It received FDA 510(k) clearance on 2020-10-05 under 510(k) number K200031. 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 Neonatal Phototherapy System?

Neonatal Phototherapy System is a medical device that received FDA 510(k) clearance on 2020-10-05. The listed applicant is Avalon Biomedical (Shenzhen) Limited. The 510(k) number is K200031.

When did Neonatal Phototherapy System receive FDA 510(k) clearance?

Neonatal Phototherapy System received FDA 510(k) clearance on 2020-10-05, under 510(k) number K200031.

Who is the listed applicant for Neonatal Phototherapy System?

The FDA 510(k) record lists Avalon Biomedical (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neonatal Phototherapy System?

The FDA product code for Neonatal Phototherapy System is LBI.

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.K190899bili-hutLittle Sparrows Technologies, Inc.K182178neoBLUE blanket LED Phototherapy SystemNatus Medical IncorporatedK172656BiliLuxDraeger Medical Systems, Inc.

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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