K242424 is an FDA 510(k) clearance for the Bluebird Single-Use Respiratory Effort Belt. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on December 18, 2024, 125 days after receiving the submission on August 15, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K242424 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2024 |
| Decision Date | December 18, 2024 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNR - Ventilatory Effort Recorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |