The following data is part of a premarket notification filed by Medcare Flaga with the FDA for Compass M10 System.
| Device ID | K041724 |
| 510k Number | K041724 |
| Device Name: | COMPASS M10 SYSTEM |
| Classification | Ventilatory Effort Recorder |
| Applicant | MEDCARE FLAGA SIDUMULI 24 Reykjavik, IS 108 |
| Contact | Berglind Hallgrimsdottir |
| Correspondent | Berglind Hallgrimsdottir MEDCARE FLAGA SIDUMULI 24 Reykjavik, IS 108 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-24 |
| Decision Date | 2004-09-28 |
| Summary: | summary |