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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stool, Anesthesia
510(k) Number K924487
Device Name RED DOT 2515 CARDIAC SENSOR SYSTEM
Applicant
3M Health Care, Ltd.
3m Center, Bldg. 275-3e-08
P.O. Box 33275
St. Paul,  MN  55133
Applicant Contact JULIA L WANAMAKER
Correspondent
3M Health Care, Ltd.
3m Center, Bldg. 275-3e-08
P.O. Box 33275
St. Paul,  MN  55133
Correspondent Contact JULIA L WANAMAKER
Regulation Number868.6700
Classification Product Code
BRX  
Date Received09/03/1992
Decision Date 12/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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