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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 K946075
Device Name VITALOGRAPH MODEL 2120
Applicant
Vitalograph, Inc.
8347 Quivira Rd.
Lenexa,  KS  66215
Applicant Contact GARY CASEY
Correspondent
Vitalograph, Inc.
8347 Quivira Rd.
Lenexa,  KS  66215
Correspondent Contact GARY CASEY
Regulation Number868.1840
Classification Product Code
BZG  
Date Received12/05/1994
Decision Date 08/04/1995
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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