SANDMAN ELITE
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
EMBLA SYSTEMS
The following data is part of a premarket notification filed by Embla Systems with the FDA for Sandman Elite.
Pre-market Notification Details
| Device ID | K153353 |
| 510k Number | K153353 |
| Device Name: | SANDMAN ELITE |
| 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 | 2015-11-20 |
| Decision Date | 2016-06-23 |
| Summary: | summary |
Trademark Results [SANDMAN ELITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SANDMAN ELITE 75781740 2635968 Live/Registered |
NATUS MEDICAL INCORPORATED 1999-08-20 |
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