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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 K011365
Device Name VITALSAT PULSE OXIMETER, MODEL IC32000
Applicant
ISLAND CRITICAL CARE CORP.
9 MYRTLE ST.
STRATFORD, P.E.I.,  CA C1B 1P4
Applicant Contact SEAN FLANIGAN
Correspondent
ISLAND CRITICAL CARE CORP.
9 MYRTLE ST.
STRATFORD, P.E.I.,  CA C1B 1P4
Correspondent Contact SEAN FLANIGAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/04/2001
Decision Date 10/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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