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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K113865
Device Name PULTOL
Applicant
SHARP CORPORATION
1201 RICHARDSON DRIVE
SUITE 280
RICHARDSON,  TX  75080
Applicant Contact DIANE RUTHERFORD
Correspondent
SHARP CORPORATION
1201 RICHARDSON DRIVE
SUITE 280
RICHARDSON,  TX  75080
Correspondent Contact DIANE RUTHERFORD
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/30/2011
Decision Date 03/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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