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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 K122516
Device Name EMBLETTA MPR
Applicant
EMBLA SYSTEMS
1 HINES RD STE 202
KANATA,  CA K2K 3C7
Applicant Contact Jennifer Armstrong
Correspondent
EMBLA SYSTEMS
1 HINES RD STE 202
KANATA,  CA K2K 3C7
Correspondent Contact Jennifer Armstrong
Regulation Number868.2375
Classification Product Code
MNR  
Date Received08/17/2012
Decision Date 02/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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