DIAG. ULTRASOUND B-SCANNER
FDA 510(k) clearance K771869 · decided 1977-11-02
Clearance details
- K-number
- K771869
- Device name
- DIAG. ULTRASOUND B-SCANNER
- Applicant
- Accusonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-10-03
- Decision date
- 1977-11-02
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- HGL
- Device class
- 2
- Regulation number
- 884.2960
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- 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.