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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K002159
Device Name SNORE SAT RECORDER, MODEL SS41
Applicant
Sagatech Electronics, Inc.
3413 8th St., SE
Calgary, Alberta,  CA T2G3A4
Applicant Contact HEATHER PLATT-MELAX
Correspondent
Sagatech Electronics, Inc.
3413 8th St., SE
Calgary, Alberta,  CA T2G3A4
Correspondent Contact HEATHER PLATT-MELAX
Regulation Number868.2375
Classification Product Code
MNR  
Date Received07/17/2000
Decision Date 06/28/2002
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
Recalls CDRH Recalls
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