EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
FDA 510(k) clearance K900966 · decided 1990-09-12
Clearance details
- K-number
- K900966
- Device name
- EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
- Applicant
- Hitachi Medical Corp. of America
- Decision
- Substantially Equivalent
- Date received
- 1990-03-01
- Decision date
- 1990-09-12
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- HGL
- Device class
- 2
- Regulation number
- 884.2960
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.