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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 K062338
Device Name TELEVISIT
Applicant
PHD Medical
4 Innovation Dr.
Dundas,  CA L9H 7P3
Applicant Contact NANCY RUTH
Correspondent
PHD Medical
4 Innovation Dr.
Dundas,  CA L9H 7P3
Correspondent Contact NANCY RUTH
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/10/2006
Decision Date 10/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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