K240271 is an FDA 510(k) clearance for the Linshom Continuous Predictive Respiratory Monitoring System (CPRMS). This device is classified as a Monitor, Breathing Frequency (Class II - Special Controls, product code BZQ).
Submitted by Linshom Medical, Inc. (Ellicott City, US). The FDA issued a Cleared decision on September 11, 2024, 224 days after receiving the submission on January 31, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K240271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2024 |
| Decision Date | September 11, 2024 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| 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 |