DGH A-SAN PROBE HOLDER
FDA 510(k) clearance K900162 · decided 1990-02-16
Clearance details
- K-number
- K900162
- Device name
- DGH A-SAN PROBE HOLDER
- Applicant
- Jedmed Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-12
- Decision date
- 1990-02-16
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- HDR
- Device class
- 2
- Regulation number
- 884.5250
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.