510(k) K990257

KEELER PULSAIR 3000 NON CONTACT TONOMETER by Keeler Instruments, Inc. — Product Code HKX

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