K192584 is an FDA 510(k) clearance for the BEACON Caresystem Model 00002144. This device is classified as a Spirometer, Monitoring (w/wo Alarm) (Class II - Special Controls, product code BZK).
Submitted by Mermaid Care A/S (Norresundby, DK). The FDA issued a Cleared decision on December 18, 2019, 90 days after receiving the submission on September 19, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1850.
| 510(k) Number | K192584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2019 |
| Decision Date | December 18, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZK - Spirometer, Monitoring (w/wo Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1850 |