510(k) K073630
K073630 is an FDA 510(k) premarket notification submitted by Qrs Diagnostic, LLC for the device "MODIFICATION TO: BPCARD, MODEL Z-7000-0700". The FDA issued a decision of Substantially Equivalent on January 11, 2008. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Qrs Diagnostic, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2008
- Date Received
- December 26, 2007
- 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