510(k) K924760
K924760 is an FDA 510(k) premarket notification submitted by Tomey Corporation USA for the device "TOMEY PROTON TONOMETER". The FDA issued a decision of Substantially Equivalent on April 5, 1993. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Tomey Corporation USA has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 1993
- Date Received
- September 23, 1992
- 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