K073152 is an FDA 510(k) clearance for the PC-180 / PRINCE 180 EASY ECG MONITOR. This device is classified as a Recorder, Magnetic Tape, Medical (Class II - Special Controls, product code DSH).
Submitted by Shenzhen Creative Industry Co., Ltd. (Chenzhen City, CN). The FDA issued a Cleared decision on January 10, 2008, 63 days after receiving the submission on November 8, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K073152 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2007 |
| Decision Date | January 10, 2008 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSH - Recorder, Magnetic Tape, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |