510(k) K842876 ยท CBK Ventilator, Continuous, Facility Use
PORTABLE LIFECARE VENTILATOR PLV-102
| Applicant | Lifecare Services, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Aug 29, 1984 |
| Received | Jul 23, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842876
| 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. Inv Circuit Assembly Box 10 CE model number 652002. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
MNT | None listed |
| Apr 24, 2008 | Respironics, Inc. Mouthpiece, Angled 22mm CE model number FC06566. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
CBK | None listed |
| Apr 24, 2008 | Respironics, Inc. PLV-102, 100V 50/60 HZ Japanese model number 87006. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
CBK | None listed |
| Apr 24, 2008 | Respironics, Inc. Rotating Connector Packaged model number 302209. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
CBK | None listed |
| Apr 24, 2008 | Respironics, Inc. RP-Cable DC 6 w/Ring PLV RBL POR model number FC07270. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
CBK | None listed |
| Apr 24, 2008 | Respironics, Inc. RP Diaphragm Exhalation model number FC06372. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
CBK | None listed |
| Apr 24, 2008 | Respironics, Inc. RP-Leaf, Check valve-5 pk model number F33440. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
CBK | 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.