K002722 is an FDA 510(k) clearance for the DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Jawon Medical Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on September 11, 2000, 11 days after receiving the submission on August 31, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K002722 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2000 |
| Decision Date | September 11, 2000 |
| Days to Decision | 11 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 |