510(k) K960924
K960924 is an FDA 510(k) premarket notification submitted by Kowa Optimed, Inc. for the device "KOWA HAND-HELD APPLANATION TONOMETER HA-1". The FDA issued a decision of Substantially Equivalent on June 4, 1996. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Kowa Optimed, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 1996
- Date Received
- March 6, 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