510(k) K980876

ASTHMA MONITOR AM2 by Erich Jaeger GmbH & Co. KG — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1998
Date Received
March 6, 1998
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