510(k) K803159
K803159 is an FDA 510(k) premarket notification submitted by Coburn Optical Ind., Inc. for the device "AUTOMATED PERIMETERS". The FDA issued a decision of Substantially Equivalent on February 4, 1981. The device falls under product code HPT (Perimeter, Automatic, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Coburn Optical Ind., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1981
- Date Received
- December 8, 1980
- 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