SINUSON 810 ULTRASOUND SCANNER
FDA 510(k) clearance K827663 · decided 1982-08-16
Clearance details
- K-number
- K827663
- Device name
- SINUSON 810 ULTRASOUND SCANNER
- Applicant
- Am Labs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-30
- Decision date
- 1982-08-16
- Days to decision
- 47 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.