K073630 is an FDA 510(k) clearance for the MODIFICATION TO: BPCARD, MODEL Z-7000-0700. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Qrs Diagnostic, LLC (Plymouth, US). The FDA issued a Cleared decision on January 11, 2008, 16 days after receiving the submission on December 26, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K073630 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2007 |
| Decision Date | January 11, 2008 |
| Days to Decision | 16 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXN — System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |