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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 K100020
Device Name DX SERIES FINGER SENSOR
Applicant
Dixtal Medical, Inc.
101 N. Plains Industrial Rd.
Bldg. # 2
Wallingford,  CT  06492 -0000
Applicant Contact ROBERT SCHIFFMAN
Correspondent
Dixtal Medical, Inc.
101 N. Plains Industrial Rd.
Bldg. # 2
Wallingford,  CT  06492 -0000
Correspondent Contact ROBERT SCHIFFMAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/05/2010
Decision Date 03/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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