510(k) K991412

VITALOGRAPH MICRO by Vitalograph, Inc. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2000
Date Received
April 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Peak Flow, Spirometry
Device Class
Class II
Regulation Number
868.1860
Review Panel
AN
Submission Type