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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pneumotachometer
510(k) Number K884464
Device Name SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR
Applicant
Spirometrics, Inc.
33 Omni Cir.
Auburn,  ME  04210
Applicant Contact ALLEN G CYR
Correspondent
Spirometrics, Inc.
33 Omni Cir.
Auburn,  ME  04210
Correspondent Contact ALLEN G CYR
Regulation Number868.2550
Classification Product Code
JAX  
Date Received10/24/1988
Decision Date 01/19/1989
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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