510(k) K041693

WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES by Hangzhou Hua'An Medical & Health Instruments Co., — Product Code DXN

K041693 is an FDA 510(k) premarket notification submitted by Hangzhou Hua'An Medical & Health Instruments Co., for the device "WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES". The FDA issued a decision of Substantially Equivalent on Dec 2, 2004. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Hangzhou Hua'An Medical & Health Instruments Co., has 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 2, 2004
Date Received
Jun 22, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type
510(k)