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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name meter, peak flow, spirometry
510(k) Number K940836
Device Name PEAKLOG AND DISPLAY SOFTWARE
Applicant
TAMARAC SYSTEMS CORP.
4890 IRONTON ST., SUITE 6L
DENVER,  CO  80239
Applicant Contact MARCIE CONNELLY
Correspondent
TAMARAC SYSTEMS CORP.
4890 IRONTON ST., SUITE 6L
DENVER,  CO  80239
Correspondent Contact MARCIE CONNELLY
Regulation Number868.1860
Classification Product Code
BZH  
Date Received02/23/1994
Decision Date 11/01/1994
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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