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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Ac-Powered
510(k) Number K093298
Device Name PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
Applicant
KEELER INSTRUMENTS, INC.
456 PKWY.
BROOMALL,  PA  19008
Applicant Contact EUGENE VAN ARSDALE
Correspondent
KEELER INSTRUMENTS, INC.
456 PKWY.
BROOMALL,  PA  19008
Correspondent Contact EUGENE VAN ARSDALE
Regulation Number886.1930
Classification Product Code
HKX  
Date Received10/21/2009
Decision Date 12/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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