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FDA 510(k)

Hi bebe super (BT-150B)

K-Number: K251512 · 2025-09-25

ApplicantBistos Co., Ltd.
Decision Date2025-09-25
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Hi bebe super (BT-150B) 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 2025-09-25 under 510(k) number K251512. 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 (BT-150B)?

Hi bebe super (BT-150B) is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Bistos Co., Ltd.. The 510(k) number is K251512.

When did Hi bebe super (BT-150B) receive FDA 510(k) clearance?

Hi bebe super (BT-150B) received FDA 510(k) clearance on 2025-09-25, under 510(k) number K251512.

Who is the listed applicant for Hi bebe super (BT-150B)?

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 Hi bebe super (BT-150B)?

The FDA product code for Hi bebe super (BT-150B) is HGX.

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.

K232991BT-1000K210289Infant Phototherapy EquipmentK200675Hi bebe super (Models BT-150S and BT-150L)K160274Hi bebe plus

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.

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