510(k) K882805
K882805 is an FDA 510(k) premarket notification submitted by Coopervision-Cilco for the device "CILCO VILLASENOR PACHYMETER". The FDA issued a decision of Substantially Equivalent on Aug 12, 1988. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Coopervision-Cilco has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 12, 1988
- Date Received
- Jul 7, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type
- 510(k)