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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 K934502
Device Name FLOW SPIROMETER
Applicant
Healthdyne, Inc.
1850 Pkwy. Pl., 12th Floor
Marietta,  GA  30067
Applicant Contact TIM COWART
Correspondent
Healthdyne, Inc.
1850 Pkwy. Pl., 12th Floor
Marietta,  GA  30067
Correspondent Contact TIM COWART
Regulation Number868.1860
Classification Product Code
BZH  
Date Received09/14/1993
Decision Date 04/04/1994
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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