510(k) K023120

OXYCON MOBILE by Erich Jaeger GmbH — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2003
Date Received
September 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Data
Device Class
Class II
Regulation Number
868.1880
Review Panel
AN
Submission Type