510(k) K052110 ยท BZD Ventilator, Non-Continuous (Respirator)
M-SERIES PRO CPAP SYTEM
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Oct 20, 2005 |
| Received | Aug 4, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052110
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2008 | Respironics, Inc. Filters under the following brand names: a) filter std incoming 7100 CPAP qty 1 model number 1039618; b) filter reusable PLV 2/pkg model number 35220; c) LX UL Fine Filter 2 pack model number 1006193; Terminated |
BZD | None listed |
| Apr 24, 2008 | Respironics, Inc. M Series Heated Humidifier Domestic model number 1022257. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | None listed |
| Apr 24, 2008 | Respironics, Inc. Power Cord Accessory under the following brand names a) Power Cord W/C7 End Europe 5 ft model number 1039014 and b) Power Cord W/C7 End USA/CAN model number 1005894. Filter, mask, and/or accessories Terminated |
BZD | None listed |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilators accessories under the following brand names: a) REM Auto M. w/Humid, w/Smartcard A Flex US model number DSS10HS and b) REM Auto M. w/SC, w/Humid A Flex CAN model number CA51 Terminated |
BZD | None listed |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) REMStar (Tower) Ultrafine Qty 1 model number 1036915, b) REMStar Auto M. w/Humid. w/Smartcard. US model number DS500HS; c) REM Terminated |
BZD | None listed |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) REMStar M US model number DS100 and b) REMStar M w/Humid US model number DS100H. Filter, mask, and/or accessories for sleep Terminated |
BZD | None listed |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) REMStar Plus M US model number DS200; b) REMStar Plus M w/Humid AHP model number AHP200H; c) REMStar Plus M w/Humid US model n Terminated |
BZD | None listed |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) REMStar Pro2 Domestic model number 1020923; b) REMStar Pro M, w/Humid w/Smartcard US model number DS400HS; c) REMStar Pro M w/ Terminated |
BZD | None listed |
| Apr 24, 2008 | Respironics, Inc. RP M Series Pollen Filter Kit 1 pack model number 1035443. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | None listed |
| Apr 24, 2008 | Respironics, Inc. Power Supply under the following brand names: a) RP, Power Supply Assembly model number H3600-015, and b) RP, Wiring Harness, Lamp Holder model number H3600-020. Filter, mask, and/or accessories for Terminated |
BZD | None listed |
| Apr 24, 2008 | Respironics, Inc. RP-Assy, Cover, DC-5 pack model number F35933. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | None listed |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) RP-BIPAP Flow Pick-Up Tube Kit model number 332185; b) RP-BIPAP M Series Keypad model number 1038122; and c) RP-BIPAP Pro 2 /P Terminated |
BZD | None listed |
| Apr 24, 2008 | Respironics, Inc. RP C-Flex Mini Din Plug model number 1011220. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | None listed |
| Apr 24, 2008 | Respironics, Inc. RP-REM Auto w/C-FLEX/REM Pro Tubing Kit model number 1008492 and RP-REM Power Cord N. AMER model number 362524. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironic Terminated |
BZD | None listed |
| Apr 24, 2008 | Respironics, Inc. RP-REMStar Plus Keypad model number 1006852. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.