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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K915833
Device Name SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART
Applicant
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887 -4645
Applicant Contact PAUL KITTINGER
Correspondent
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887 -4645
Correspondent Contact PAUL KITTINGER
Regulation Number868.1880
Classification Product Code
BZC  
Date Received12/24/1991
Decision Date 12/02/1992
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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