510(k) K093213
K093213 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, Inc. for the device "GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES". The FDA issued a decision of Substantially Equivalent on March 12, 2010. The device falls under product code HPT (Perimeter, Automatic, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Carl Zeiss Meditec, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2010
- Date Received
- October 13, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Perimeter, Automatic, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.1605
- Review Panel
- OP
- Submission Type