SDL-10 DIAGNOSTIC ULTRASOUND
FDA 510(k) clearance K837314 · decided 1983-04-29
Clearance details
- K-number
- K837314
- Device name
- SDL-10 DIAGNOSTIC ULTRASOUND
- Applicant
- Shimadzu Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-22
- Decision date
- 1983-04-29
- Days to decision
- 38 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Kyoto City 604 Japan, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.