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FDA 510(k)

Infant Phototherapy Equipment

K-Number: K210289 · 2021-05-28

ApplicantBistos Co., Ltd.
Decision Date2021-05-28
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infant Phototherapy Equipment is the device name listed in this FDA 510(k) record. The listed applicant is Bistos Co., Ltd.. It received FDA 510(k) clearance on 2021-05-28 under 510(k) number K210289. 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 Infant Phototherapy Equipment?

Infant Phototherapy Equipment is a medical device that received FDA 510(k) clearance on 2021-05-28. The listed applicant is Bistos Co., Ltd.. The 510(k) number is K210289.

When did Infant Phototherapy Equipment receive FDA 510(k) clearance?

Infant Phototherapy Equipment received FDA 510(k) clearance on 2021-05-28, under 510(k) number K210289.

Who is the listed applicant for Infant Phototherapy Equipment?

The FDA 510(k) record lists Bistos Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infant Phototherapy Equipment?

The FDA product code for Infant Phototherapy Equipment is LBI.

Other records listing Bistos Co., Ltd. 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.K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) LimitedK190899bili-hutLittle Sparrows Technologies, Inc.K182178neoBLUE blanket LED Phototherapy SystemNatus Medical IncorporatedK172656BiliLuxDraeger Medical Systems, Inc.

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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