K081983 is an FDA 510(k) clearance for the M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on August 22, 2008, 42 days after receiving the submission on July 11, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K081983 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2008 |
| Decision Date | August 22, 2008 |
| Days to Decision | 42 days |
| Submission Type | Special |
| 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 |