The following data is part of a premarket notification filed by Mermaid Care A/s with the FDA for Beacon Caresystem Model 00002144.
| Device ID | K192584 |
| 510k Number | K192584 |
| Device Name: | BEACON Caresystem Model 00002144 |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | Mermaid Care A/S Hedelund 1 Norresundby, DK Dk-0400 |
| Contact | Claus Lindholt |
| Correspondent | Claus Lindholt Mermaid Care A/S Hedelund 1 Norresundby, DK Dk-0400 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-19 |
| Decision Date | 2019-12-18 |