BT-350
FDA 510(k) clearance K103545 · decided 2011-05-13
Clearance details
- K-number
- K103545
- Device name
- BT-350
- Applicant
- Bistos Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-12-02
- Decision date
- 2011-05-13
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Brooklyn, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.