510(k) K900162
K900162 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "DGH A-SAN PROBE HOLDER". The FDA issued a decision of Substantially Equivalent on February 16, 1990. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 1990
- Date Received
- January 12, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cap, Cervical
- Device Class
- Class II
- Regulation Number
- 884.5250
- Review Panel
- OB
- Submission Type