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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 K013489
Device Name KP + LFM
Applicant
PDS HEALTHCARE PRODUCTS, INC.
908 MAIN ST.
LOUISVILLE,  CO  80027
Applicant Contact JIM LEWIS
Correspondent
PDS HEALTHCARE PRODUCTS, INC.
908 MAIN ST.
LOUISVILLE,  CO  80027
Correspondent Contact JIM LEWIS
Regulation Number868.1860
Classification Product Code
BZH  
Date Received10/22/2001
Decision Date 11/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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