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Hi bebe super (BT-150B) — Bistos Co., Ltd. (510(k) K251512)

Hi bebe super (BT-150B) — Bistos Co., Ltd. (510(k) K251512) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Hi bebe super (BT-150B); Applicant: Bistos Co., Ltd.; Clearance track: 510(k).

Device nameHi bebe super (BT-150B)
ApplicantBistos Co., Ltd.
Clearance track510(k)
Submission numberK251512
DecisionSubstantially Equivalent
Decision date2025-09-25
Date received2025-05-16
Product codeHGX
Device class2
Medical specialtyObstetrics/Gynecology
Applicant locationKR
SourceopenFDA device

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