510(k) K041010 ยท BZD Ventilator, Non-Continuous (Respirator)
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, May 5, 2004 |
| Received | Apr 20, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041010
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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. 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.