FDA 510(k)

Hi bebe plus

K-Number: K160274 · 2016-09-01

Decision Date2016-09-01

Product CodeHGX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Hi bebe plus is a medical device manufactured by Bistos Co., Ltd.. It received FDA 510(k) clearance on 2016-09-01 under approval number K160274. 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 plus?

Hi bebe plus is a medical device that received FDA 510(k) clearance on 2016-09-01. It is manufactured by Bistos Co., Ltd.. The 510(k) number is K160274.

When was Hi bebe plus approved by the FDA?

Hi bebe plus received FDA 510(k) clearance on 2016-09-01, under approval number K160274.

What company makes Hi bebe plus?

Hi bebe plus is manufactured by Bistos Co., Ltd..

What is the FDA product code for Hi bebe plus?

The FDA product code for Hi bebe plus is HGX.

Other Devices by Bistos Co., Ltd.

K210289Infant Phototherapy Equipment K200675Hi bebe super (Models BT-150S and BT-150L) K232991BT-1000 K251512Hi bebe super (BT-150B)

Related Devices (Code: HGX)

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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.