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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, breathing frequency
510(k) Number K853252
Device Name EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM
Applicant
EMERGENT TECHNOLOGY CORP.
14 CODDING RD.
ATTLEBORO,  MA  02703
Applicant Contact WILLIAM A MORTON
Correspondent
EMERGENT TECHNOLOGY CORP.
14 CODDING RD.
ATTLEBORO,  MA  02703
Correspondent Contact WILLIAM A MORTON
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received08/02/1985
Decision Date 01/21/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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