The following data is part of a premarket notification filed by Embla Systems with the FDA for Remlogic.
| Device ID | K162140 |
| 510k Number | K162140 |
| Device Name: | RemLogic |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Applicant | EMBLA SYSTEMS 1 HINES ROAD SUITE 202 Kanata, CA K2k 3c7 |
| Contact | Shane T. Sawall |
| Correspondent | Shane T. Sawall EMBLA SYSTEMS 1 HINES ROAD SUITE 202 Kanata, CA K2k 3c7 |
| Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-01 |
| Decision Date | 2016-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830048484 | K162140 | 000 |