BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL
FDA 510(k) clearance K873673 · decided 1988-02-26
Clearance details
- K-number
- K873673
- Device name
- BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL
- Applicant
- Sonicaid, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-09-11
- Decision date
- 1988-02-26
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- DPT
- Device class
- 2
- Regulation number
- 870.2120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Clearwater, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.