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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
510(k) Number K894361
Device Name LIFECARE PRESSURE ALARM CAT. NO. 34-010
Applicant
LIFECARE SERVICES, INC.
655 ASPEN RIDGE DR.
LAFAYETTE,  CO  80026
Applicant Contact HAROLD ELLERINGTON
Correspondent
LIFECARE SERVICES, INC.
655 ASPEN RIDGE DR.
LAFAYETTE,  CO  80026
Correspondent Contact HAROLD ELLERINGTON
Regulation Number868.2600
Classification Product Code
CAP  
Date Received07/14/1989
Decision Date 10/05/1989
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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