K011540 is an FDA 510(k) clearance for the VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Datascope Corp. (Mahwh, US). The FDA issued a Cleared decision on February 6, 2002, 264 days after receiving the submission on May 18, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K011540 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2001 |
| Decision Date | February 06, 2002 |
| Days to Decision | 264 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MHX - Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |