FDA 510(k)

Hi bebe super (Models BT-150S and BT-150L)

K-Number: K200675 · 2021-02-10

Decision Date2021-02-10

Product CodeHGX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Hi bebe super (Models BT-150S and BT-150L) is a medical device manufactured by Bistos Co., Ltd.. It received FDA 510(k) clearance on 2021-02-10 under approval number K200675. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hi bebe super (Models BT-150S and BT-150L)?

Hi bebe super (Models BT-150S and BT-150L) is a medical device that received FDA 510(k) clearance on 2021-02-10. It is manufactured by Bistos Co., Ltd.. The 510(k) number is K200675.

When was Hi bebe super (Models BT-150S and BT-150L) approved by the FDA?

Hi bebe super (Models BT-150S and BT-150L) received FDA 510(k) clearance on 2021-02-10, under approval number K200675.

What company makes Hi bebe super (Models BT-150S and BT-150L)?

Hi bebe super (Models BT-150S and BT-150L) is manufactured by Bistos Co., Ltd..

What is the FDA product code for Hi bebe super (Models BT-150S and BT-150L)?

The FDA product code for Hi bebe super (Models BT-150S and BT-150L) is HGX.

Other Devices by Bistos Co., Ltd.

K160274Hi bebe plus K210289Infant Phototherapy Equipment K232991BT-1000 K251512Hi bebe super (BT-150B)

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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.