The following data is part of a premarket notification filed by Somnomedics Gmbh with the FDA for Somnoscreen Eeg10-20.
| Device ID | K071556 |
| 510k Number | K071556 |
| Device Name: | SOMNOSCREEN EEG10-20 |
| Classification | Ventilatory Effort Recorder |
| Applicant | SOMNOMEDICS GMBH 719 A STREET NE Washington, DC 20002 |
| Contact | Cherita James |
| Correspondent | Cherita James SOMNOMEDICS GMBH 719 A STREET NE Washington, DC 20002 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-07 |
| Decision Date | 2007-07-18 |
| Summary: | summary |