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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Driver, Wire, And Bone Drill, Manual
510(k) Number K915848
Device Name SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.
Applicant
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Applicant Contact PAUL L KITTINGER
Correspondent
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Correspondent Contact PAUL L KITTINGER
Regulation Number872.4120
Classification Product Code
DZJ  
Date Received12/26/1991
Decision Date 10/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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