K062278 is an FDA 510(k) clearance for the SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).
Submitted by Spacelabs Medical, Inc. (Issaquah, US). The FDA issued a Cleared decision on September 19, 2006, 43 days after receiving the submission on August 7, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K062278 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2006 |
| Decision Date | September 19, 2006 |
| Days to Decision | 43 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MSX — System, Network And Communication, Physiological Monitors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |