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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 K920246
Device Name SENSORMEDICS MODEL 922 SPIROMETER
Applicant
SENSORMEDICS CORP.
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Applicant Contact PAUL L KITTINGER
Correspondent
SENSORMEDICS CORP.
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Correspondent Contact PAUL L KITTINGER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received01/21/1992
Decision Date 04/08/1992
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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