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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K911874
Device Name SLEEPTRACE 2000
Applicant
Areca Science Corp.
991 Commercial Ave.
Palo Alto,  CA  94303
Applicant Contact KEVIN MCHALE
Correspondent
Areca Science Corp.
991 Commercial Ave.
Palo Alto,  CA  94303
Correspondent Contact KEVIN MCHALE
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received04/29/1991
Decision Date 06/25/1992
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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