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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K004050
Device Name PANASONIC TELE-HOMECARE SYSTEM
Applicant
Matsushita Electric Industrial Co., Ltd.
1801 Rockville Pike
Rockville,  MD  20852
Applicant Contact DAVID L WEST
Correspondent
Matsushita Electric Industrial Co., Ltd.
1801 Rockville Pike
Rockville,  MD  20852
Correspondent Contact DAVID L WEST
Regulation Number870.2300
Classification Product Code
MWI  
Date Received12/29/2000
Decision Date 03/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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