510(k) K170281

MSA100BT Peak Flow Meter by Beijing M&B Electronic Instruments Co., Ltd. — Product Code BZH

K170281 is an FDA 510(k) premarket notification submitted by Beijing M&B Electronic Instruments Co., Ltd. for the device "MSA100BT Peak Flow Meter". The FDA issued a decision of Substantially Equivalent on October 6, 2017. 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 6, 2017
Date Received
January 30, 2017
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