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510(k) K093298

PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 by Keeler Instruments, Inc. — Product Code HKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2010
Date Received
October 21, 2009
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

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