K243270 is an FDA 510(k) clearance for the TigerConnect Alarm Management. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).
Submitted by Tigerconnect (Santa Monica, US). The FDA issued a Cleared decision on September 30, 2025, 349 days after receiving the submission on October 16, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K243270 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2024 |
| Decision Date | September 30, 2025 |
| Days to Decision | 349 days |
| Submission Type | Traditional |
| 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 |