SANDMAN ELITE — Embla Systems (510(k) K153353)
SANDMAN ELITE — Embla Systems (510(k) K153353) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: SANDMAN ELITE; Applicant: Embla Systems; Clearance track: 510(k).
| Device name | SANDMAN ELITE |
|---|---|
| Applicant | Embla Systems |
| Clearance track | 510(k) |
| Submission number | K153353 |
| Decision | Substantially Equivalent |
| Decision date | 2016-06-23 |
| Date received | 2015-11-20 |
| Product code | OLZ |
| Device class | 2 |
| Medical specialty | Neurology |
| Applicant location | CA |
| Source | openFDA device |
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$1999/mo
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