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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 K023225
Device Name PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
Applicant
PURITAN BENNETT CORP.
4280 HACIENDA DR.
PLEASANTON,  CA  94588 -2719
Applicant Contact GINA TO
Correspondent
PURITAN BENNETT CORP.
4280 HACIENDA DR.
PLEASANTON,  CA  94588 -2719
Correspondent Contact GINA TO
Regulation Number868.1840
Classification Product Code
BZG  
Date Received09/27/2002
Decision Date 12/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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