510(k) K991569 ยท CAW Generator, Oxygen, Portable
HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2
| Applicant | 02 Marketing Group, Inc., Roswell GA, US |
| Decision | Substantially Equivalent, Aug 3, 1999 |
| Received | May 5, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991569
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2003 | System 02 Inc System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 6 liters per minute volumetr Terminated |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.