K242842 is an FDA 510(k) clearance for the ANNE View, Central Hub. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).
Submitted by Sibel Health, Inc. (Chicago, US). The FDA issued a Cleared decision on January 8, 2025, 111 days after receiving the submission on September 19, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K242842 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2024 |
| Decision Date | January 08, 2025 |
| Days to Decision | 111 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 |