Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Hi bebe plus

K-Number: K160274 · 2016-09-01

ApplicantBistos Co., Ltd.
Decision Date2016-09-01
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Hi bebe plus 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 2016-09-01 under 510(k) 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. The listed applicant is Bistos Co., Ltd.. The 510(k) number is K160274.

When did Hi bebe plus receive FDA 510(k) clearance?

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

Who is the listed applicant for Hi bebe plus?

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 plus?

The FDA product code for Hi bebe plus 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.

K251512Hi bebe super (BT-150B)K232991BT-1000K210289Infant Phototherapy EquipmentK200675Hi bebe super (Models BT-150S and BT-150L)

Related Devices (Code: HGX)

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.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.

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.

↑