510(k) K180839
K180839 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, AG for the device "AT 030". The FDA issued a decision of Substantially Equivalent on June 7, 2018. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Carl Zeiss Meditec, AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2018
- Date Received
- March 30, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer, Manual
- Device Class
- Class II
- Regulation Number
- 886.1930
- Review Panel
- OP
- Submission Type