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 a medical device manufactured by Bistos Co., Ltd.. It received FDA 510(k) clearance on 2021-05-28 under approval 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. It is manufactured by Bistos Co., Ltd.. The 510(k) number is K210289.
When was Infant Phototherapy Equipment approved by the FDA?
Infant Phototherapy Equipment received FDA 510(k) clearance on 2021-05-28, under approval number K210289.
What company makes Infant Phototherapy Equipment?
Infant Phototherapy Equipment is manufactured by Bistos Co., Ltd..
What is the FDA product code for Infant Phototherapy Equipment?
The FDA product code for Infant Phototherapy Equipment is LBI.
Other Devices by Bistos Co., Ltd.
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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.