510(k) K092335

PEAK EXPIRATORY FLOW METER, KN-9710 by K-Jump Health Co., Ltd. — Product Code BZH

K092335 is an FDA 510(k) premarket notification submitted by K-Jump Health Co., Ltd. for the device "PEAK EXPIRATORY FLOW METER, KN-9710". The FDA issued a decision of Substantially Equivalent on April 9, 2010. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860. K-Jump Health Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2010
Date Received
August 4, 2009
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