510(k) K123896

CCS-200 SPIROMETER by Benson Medical Instruments Co. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2013
Date Received
December 18, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type