510(k) K040012
K040012 is an FDA 510(k) premarket notification submitted by Zoe Medical, Inc. for the device "WELL@HOME SYSTEM". The FDA issued a decision of Substantially Equivalent on Apr 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. Zoe Medical, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 2, 2004
- Date Received
- Jan 5, 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)