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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
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