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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K943678
Device Name ELECTRONIC FLOW METER
Applicant
VITALOGRAPH, INC.
8347 QUIVIRA RD.
LENEXA,  KS  66215
Applicant Contact ALAN DUNNE
Correspondent
VITALOGRAPH, INC.
8347 QUIVIRA RD.
LENEXA,  KS  66215
Correspondent Contact ALAN DUNNE
Regulation Number868.1860
Classification Product Code
BZH  
Date Received07/26/1994
Decision Date 12/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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