K990563 is an FDA 510(k) clearance for the SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on March 19, 1999, 25 days after receiving the submission on February 22, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K990563 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 1999 |
| Decision Date | March 19, 1999 |
| Days to Decision | 25 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 |