510(k) K180858
K180858 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, AG for the device "CALLISTO eye". The FDA issued a decision of Substantially Equivalent on Jun 27, 2018. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050. Carl Zeiss Meditec, AG has 75 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 27, 2018
- Date Received
- Apr 2, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Management, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- OP
- Submission Type
- 510(k)