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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K101834
FOIA Releasable 510(k) K101834
Device Name 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM
Applicant
3M Company
3m Center, Bldg. 275-05-W-06
St. Paul,  MN  55144 -1000
Applicant Contact JIZHONG JIN
Correspondent
3M Company
3m Center, Bldg. 275-05-W-06
St. Paul,  MN  55144 -1000
Correspondent Contact JIZHONG JIN
Regulation Number870.2910
Classification Product Code
DRG  
Date Received07/01/2010
Decision Date 09/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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