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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 K024322
FOIA Releasable 510(k) K024322
Device Name EMBLA N7000
Applicant
Medcare Flaga
46 Loch Haven Ln.
Battle Creek,  MI  49015
Applicant Contact KUMAR KULKARNI
Correspondent
Medcare Flaga
46 Loch Haven Ln.
Battle Creek,  MI  49015
Correspondent Contact KUMAR KULKARNI
Regulation Number868.2375
Classification Product Code
MNR  
Date Received12/26/2002
Decision Date 10/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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