K050605 is an FDA 510(k) clearance for the SPACELABS MEDICAL MULTIPARAMETER MODULE 91496. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Spacelabs Medical, Inc. (Issaquah, US). The FDA issued a Cleared decision on May 3, 2005, 54 days after receiving the submission on March 10, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K050605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2005 |
| Decision Date | May 03, 2005 |
| Days to Decision | 54 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSI — Detector And Alarm, Arrhythmia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |