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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 K020607
Device Name SLEEPFLO, MODEL 101501
Applicant
Biomec, Inc.
1771 E. 30th St.
Cleveland,  OH  44114
Applicant Contact TRACEY H WIELINSKI
Correspondent
Biomec, Inc.
1771 E. 30th St.
Cleveland,  OH  44114
Correspondent Contact TRACEY H WIELINSKI
Regulation Number868.2375
Classification Product Code
MNR  
Date Received02/25/2002
Decision Date 08/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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