510(k) K961512
K961512 is an FDA 510(k) premarket notification submitted by Clement Clarke, Inc. for the device "PERKINS HAND-HELD APPLANATION TONOMETER". The FDA issued a decision of Substantially Equivalent on July 18, 1996. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Clement Clarke, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 1996
- Date Received
- April 19, 1996
- 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