510(k) K093931
K093931 is an FDA 510(k) premarket notification submitted by Citizen Systems Japan Co., Ltd. for the device "BLOOD PRESSURE METER, MODEL CH-4532". The FDA issued a decision of Substantially Equivalent on Jun 10, 2010. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Citizen Systems Japan Co., Ltd. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 10, 2010
- Date Received
- Dec 22, 2009
- Clearance Type
- Special
- 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)