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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 EAST 30TH ST.
CLEVELAND,  OH  44114 -4407
Applicant Contact TRACEY H WIELINSKI
Correspondent
BIOMEC, INC.
1771 EAST 30TH ST.
CLEVELAND,  OH  44114 -4407
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
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