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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 K991412
Device Name VITALOGRAPH MICRO
Applicant
Vitalograph, Inc.
8347 Quivira Rd.
Lenexa,  KS  66215
Applicant Contact PHIL HEMES
Correspondent
Vitalograph, Inc.
8347 Quivira Rd.
Lenexa,  KS  66215
Correspondent Contact PHIL HEMES
Regulation Number868.1860
Classification Product Code
BZH  
Date Received04/23/1999
Decision Date 02/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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