510(k) K984031

SPIROVIT, MODEL SP-250 by Schiller AG — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1999
Date Received
November 12, 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