BT-1000
FDA 510(k) clearance K232991 · decided 2024-08-28
Clearance details
- K-number
- K232991
- Device name
- BT-1000
- Applicant
- Bistos Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-22
- Decision date
- 2024-08-28
- Days to decision
- 341 days
- Clearance type
- Traditional
- Product code
- QGL
- Device class
- 2
- Regulation number
- 882.5898
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Gyeonggi, KR
- Third-party review
- No
- Expedited review
- No
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| ADDNOX (BPSPM1) (K243289) | Nu Eyne Co., Ltd. | 2025-01-16 |
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| SMILE (K213629) | Nu Eyne Co., Ltd. | 2023-02-12 |
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Recalls involving this device
No recalls on record reference this clearance.