510(k) K031024

MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 by Microlife Corp. — Product Code BZH

K031024 is an FDA 510(k) premarket notification submitted by Microlife Corp. for the device "MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100". The FDA issued a decision of Substantially Equivalent on November 14, 2003. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860. Microlife Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2003
Date Received
March 31, 2003
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