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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 K980441
Device Name SPIROMETER MODEL NPB-500
Applicant
NELLCOR PURITAN BENNETT, INC.
11150 THOMPSON AVE.
LENEXA,  KS  66219 -2301
Applicant Contact DAVID GREEN
Correspondent
NELLCOR PURITAN BENNETT, INC.
11150 THOMPSON AVE.
LENEXA,  KS  66219 -2301
Correspondent Contact DAVID GREEN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received02/04/1998
Decision Date 04/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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