510(k) K071397 ยท CAW Generator, Oxygen, Portable
DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES
| Applicant | Sunrise Medical, Somerset PA, US |
| Decision | Substantially Equivalent, Oct 1, 2007 |
| Received | May 21, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071397
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2025 | Medical Depot Inc. iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle. Open, Classified |
CAW | None listed |
| May 4, 2023 | DeVilbiss Healthcare LLC DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR Open, Classified |
CAW | None listed |
| Dec 19, 2022 | DeVilbiss Healthcare LLC DeVilbiss, 525 5-liter Oxygen Concentrator
Models 525DS, 525DS-Q Open, Classified |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.