K032733 is an FDA 510(k) clearance for the PM-8000 PATIENT MONITOR, MODEL 8000. This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II - Special Controls, product code DRT).
Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on March 3, 2004, 181 days after receiving the submission on September 4, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K032733 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2003 |
| Decision Date | March 03, 2004 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRT — Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |