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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 K944762
Device Name PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
Applicant
Puritan Bennett Corp.
255 Ballardvale St.
Wilmington,  MA  01887
Applicant Contact C M SMITH
Correspondent
Puritan Bennett Corp.
255 Ballardvale St.
Wilmington,  MA  01887
Correspondent Contact C M SMITH
Regulation Number868.1840
Classification Product Code
BZG  
Date Received09/27/1994
Decision Date 12/13/1994
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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