The following data is part of a premarket notification filed by Widemed Ltd with the FDA for Morpheus Ox.
| Device ID | K111314 |
| 510k Number | K111314 |
| Device Name: | MORPHEUS OX |
| Classification | Ventilatory Effort Recorder |
| Applicant | WIDEMED LTD 10, HA'SADNAOT ST. Herzliya, IL 46733 |
| Contact | John Smith |
| Correspondent | John Smith WIDEMED LTD 10, HA'SADNAOT ST. Herzliya, IL 46733 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-10 |
| Decision Date | 2011-08-31 |
| Summary: | summary |