510(k) K880550

BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS by Medimicro Systems, Inc. — Product Code BZM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1988
Date Received
February 9, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Interpretor (Diagnostic)
Device Class
Class II
Regulation Number
868.1900
Review Panel
AN
Submission Type