The following data is part of a premarket notification filed by Widemed Ltd with the FDA for Morpheus 1, Automated Sleep Study Scoring & Data Management System.
| Device ID | K022506 |
| 510k Number | K022506 |
| Device Name: | MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM |
| Classification | Ventilatory Effort Recorder |
| Applicant | WIDEMED LTD OMER INDUSTRIAL PARK, BLDG 8C POB 3002 Omer, IL 84965 |
| Contact | David Solomon |
| Correspondent | David Solomon WIDEMED LTD OMER INDUSTRIAL PARK, BLDG 8C POB 3002 Omer, IL 84965 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-30 |
| Decision Date | 2003-05-15 |
| Summary: | summary |