K223246 is an FDA 510(k) clearance for the Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense. This device is classified as a Monitor, Breathing Frequency (Class II - Special Controls, product code BZQ).
Submitted by Baxter Healthcare Corproration (Batesville, US). The FDA issued a Cleared decision on November 18, 2022, 29 days after receiving the submission on October 20, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K223246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2022 |
| Decision Date | November 18, 2022 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZQ — Monitor, Breathing Frequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |