510(k) K990257
K990257 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "KEELER PULSAIR 3000 NON CONTACT TONOMETER". The FDA issued a decision of Substantially Equivalent on March 25, 1999. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 1999
- Date Received
- January 27, 1999
- 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