K040945 is an FDA 510(k) clearance for the MODIFICATION TO INFINITY EXPLORER. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).
Submitted by Draeger Medical Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on May 12, 2004, 30 days after receiving the submission on April 12, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K040945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2004 |
| Decision Date | May 12, 2004 |
| Days to Decision | 30 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 |