510(k) K982454 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
BIPAP VISION VENTILATORY SUPPORT
| Applicant | Respironics, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Nov 3, 1998 |
| Received | Jul 15, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982454
| 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 |
| Apr 24, 2008 | Respironics, Inc. Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5 pk model number F35465; b) RP-Seal, Greece, Ballscrew model number F35036; c) RP-Tub PVC 1/8 in x 50 ft model n Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.