510(k) K022054
K022054 is an FDA 510(k) premarket notification submitted by C.S.O. S.R.L. for the device "F 900". The FDA issued a decision of Substantially Equivalent on August 6, 2002. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. C.S.O. S.R.L. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 2002
- Date Received
- June 24, 2002
- 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