BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM
FDA 510(k) clearance K837063 · decided 1983-04-04
Clearance details
- K-number
- K837063
- Device name
- BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM
- Applicant
- Biosound, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-17
- Decision date
- 1983-04-04
- Days to decision
- 77 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.