The following data is part of a premarket notification filed by Widemed Ltd with the FDA for Noga Automated Sleep Study Scoring And Data Management System.
| Device ID | K070326 |
| 510k Number | K070326 |
| Device Name: | NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM |
| Classification | Ventilatory Effort Recorder |
| Applicant | WIDEMED LTD 7 JABOTINSKY ST Ramat Gan, IL 52520 |
| Contact | Dorit Winitz |
| Correspondent | Dorit Winitz WIDEMED LTD 7 JABOTINSKY ST Ramat Gan, IL 52520 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-05 |
| Decision Date | 2007-05-05 |
| Summary: | summary |