The following data is part of a premarket notification filed by Younes Sleep Technologies with the FDA for Michele Sleep Scoring Systems.
| Device ID | K112102 |
| 510k Number | K112102 |
| Device Name: | MICHELE SLEEP SCORING SYSTEMS |
| Classification | Ventilatory Effort Recorder |
| Applicant | YOUNES SLEEP TECHNOLOGIES 435 ELLICE AVENUE Winnipeg, Manitoba, CA R3b 1y6 |
| Contact | Magdy Younes |
| Correspondent | Magdy Younes YOUNES SLEEP TECHNOLOGIES 435 ELLICE AVENUE Winnipeg, Manitoba, CA R3b 1y6 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-22 |
| Decision Date | 2011-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B6005537160 | K112102 | 000 |