510(k) K022124

GALEMED PEAK FLOW METER, MODELS 3751/3752 by Galemed Corp. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2003
Date Received
July 1, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Peak Flow, Spirometry
Device Class
Class II
Regulation Number
868.1860
Review Panel
AN
Submission Type