510(k) K820035

CDX 200 by Cdx Corp. — Product Code BZM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1982
Date Received
January 7, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Interpretor (Diagnostic)
Device Class
Class II
Regulation Number
868.1900
Review Panel
AN
Submission Type