510(k) K963079
K963079 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "CANON TX-10 TONOMETER". The FDA issued a decision of Substantially Equivalent on March 3, 1997. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Canon USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 3, 1997
- Date Received
- August 7, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1930
- Review Panel
- OP
- Submission Type