510(k) K111378 ยท MNS Ventilator, Continuous, Non-Life-Supporting
OXIMETRY INTERFACE KIT
| Applicant | Philips Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Oct 4, 2011 |
| Received | May 17, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111378
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2021 | Philips Respironics, Inc. DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting
The Philips Respironics E30 ventilator is Open, Classified |
MNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.