| Primary Device ID | B14350201490 |
| NIH Device Record Key | 4e31a09b-e804-47db-a739-8fbd51145f92 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SleepScout |
| Version Model Number | Computer Unit |
| Catalog Number | 502-0149 |
| Company DUNS | 557510625 |
| Company Name | Cleveland Medical Devices Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B14350201490 [Primary] |
| GWQ | Full-Montage Standard Electroencephalograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
| B14360201292 | Optional accessory kit for use with SleepScout - International customers |
| B14360200511 | Optional accessory kit for use with SleepScout |
| B14350201490 | SleepScout Computer Unit for recording/viewing SleepScout acquisition data in real time on a PC. |
| B143502014610 | Wireless portable sleep monitor for sleep testing |
| B14350101320 | Sapphire Computer Unit for recording/viewing Sapphire acquisition data in real time on a PC. |
| B14350100280 | SPO2 Interface cable for use with SleepScout PSG system |