510(k) K070750

247 BP DEVICE by Suntech Medical, Inc. — Product Code DXN

K070750 is an FDA 510(k) premarket notification submitted by Suntech Medical, Inc. for the device "247 BP DEVICE". The FDA issued a decision of Substantially Equivalent on May 2, 2007. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Suntech Medical, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2007
Date Received
March 19, 2007
Clearance Type
Abbreviated
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