K083078 is an FDA 510(k) clearance for the QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Quanta Computer, Inc. (Flagstaff, US). The FDA issued a Cleared decision on November 26, 2008, 41 days after receiving the submission on October 16, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K083078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2008 |
| Decision Date | November 26, 2008 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| 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 |