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 name | Hi bebe super (BT-150B) |
|---|---|
| Applicant | Bistos Co., Ltd. |
| Clearance track | 510(k) |
| Submission number | K251512 |
| Decision | Substantially Equivalent |
| Decision date | 2025-09-25 |
| Date received | 2025-05-16 |
| Product code | HGX |
| Device class | 2 |
| Medical specialty | Obstetrics/Gynecology |
| Applicant location | KR |
| Source | openFDA device |
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