510(k) K071509 ยท MNS Ventilator, Continuous, Non-Life-Supporting
BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM
| Applicant | Respironics Inc., Sleep & Home Respiratory Group, Murrysville PA, US |
| Decision | Substantially Equivalent, Aug 8, 2007 |
| Received | Jun 4, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071509
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2008 | Respironics, Inc. Omni Lab Core Domestic model number 1043343. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
MNS | None listed |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilators under the following brand names: a) Sync S/T Lab, w/o modem US/CAN model number 1010771; b) Sync S/T Lab, w/o modem US/CAN-RENT model number R1010771; c) Synchrony S w/o mod Terminated |
MNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.