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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K894680
Device Name RS232 FLOW SENSOR AND SOFTWARE PACKAGE
Applicant
Tamarac Systems Corp.
4890 Ironton St., Suite 6l
Denver,  CO  80239
Applicant Contact MARILYN CONNELLY-LYN
Correspondent
Tamarac Systems Corp.
4890 Ironton St., Suite 6l
Denver,  CO  80239
Correspondent Contact MARILYN CONNELLY-LYN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received07/25/1989
Decision Date 10/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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