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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 K914219
Device Name AIRWAY THERMISTOR
Applicant
Synectics-Dantec
1425 Greenway Dr.
Suite 600
Irving,  TX  75038
Applicant Contact ANNA PETTERSSON
Correspondent
Synectics-Dantec
1425 Greenway Dr.
Suite 600
Irving,  TX  75038
Correspondent Contact ANNA PETTERSSON
Regulation Number868.1840
Classification Product Code
BZG  
Date Received09/19/1991
Decision Date 02/26/1992
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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