510(k) K040595 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
ALICE 5
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Mar 18, 2004 |
| Received | Mar 8, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K040595
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number 1016360; b) O2 Enrichment Attachment BX 10 model number 312010; c) O2 Enrichment Attachment Terminated |
GWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.