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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, apnea, facility use
510(k) Number K011597
Device Name SMARTMONITOR 2, MODEL 4000
Applicant
RESPIRONICS GEORGIA, INC.
175 CHASTAIN MEADOWS COURT
KENNESAW,  GA  30144
Applicant Contact BETSY CORTELLONI
Correspondent
RESPIRONICS GEORGIA, INC.
175 CHASTAIN MEADOWS COURT
KENNESAW,  GA  30144
Correspondent Contact BETSY CORTELLONI
Regulation Number868.2377
Classification Product Code
FLS  
Date Received05/24/2001
Decision Date 01/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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