510(k) K010263 ยท BZD Ventilator, Non-Continuous (Respirator)
REMSTAR PLUS CPAP SYSTEM
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Mar 29, 2001 |
| Received | Jan 29, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010263
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2008 | Respironics, Inc. REMStar Heated Humidifier Pkg model number 1005792. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | None listed |
| Jan 10, 2007 | Respironics, Inc. REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861. Terminated |
BTT | None listed |
| Jan 10, 2007 | Respironics, Inc. REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265 Terminated |
BTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.