510(k) K131882 ยท OLT Non-Normalizing Quantitative Electroencephalograph Software
GEODESICEEG SYSTEM 400 SERIES (GES 400)
| Applicant | Electrical Geodesics, Inc., Eugene OR, US |
| Decision | Substantially Equivalent, Feb 12, 2014 |
| Received | Jun 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131882
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2021 | Philips Respironics, Inc. SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators
The Philips Respironics E30 ventilator is intended to provide invasive and non-in Open, Classified |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.