510(k) K062027
K062027 is an FDA 510(k) premarket notification submitted by A&D Engineering, Inc. for the device "A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on January 19, 2007. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. A&D Engineering, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 2007
- Date Received
- July 18, 2006
- 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