510(k) K133975

MSA100 PEAK FLOW METER by Beijing M&B Electronic Instruments Co., Ltd. — Product Code BZH

K133975 is an FDA 510(k) premarket notification submitted by Beijing M&B Electronic Instruments Co., Ltd. for the device "MSA100 PEAK FLOW METER". The FDA issued a decision of Substantially Equivalent on October 3, 2014. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860. Beijing M&B Electronic Instruments Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2014
Date Received
December 26, 2013
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