510(k) K964702
K964702 is an FDA 510(k) premarket notification submitted by Euclid Systems Corp. for the device "EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800". The FDA issued a decision of Substantially Equivalent on May 20, 1997. The device falls under product code MMQ (Topographer, Corneal, Ac-Powered), a Class I device regulated under 21 CFR 886.1350.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 1997
- Date Received
- November 25, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Topographer, Corneal, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.1350
- Review Panel
- OP
- Submission Type