510(k) K992823

SPIROVIT SP-2, PNEUMOCHECK II by Schiller AG — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2000
Date Received
August 23, 1999
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