510(k) K982215 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
MANUAL RESUSCITATOR WITH ACE
| Applicant | Medical Marketing Concepts, Crofton MD, US |
| Decision | Substantially Equivalent, Sep 18, 1998 |
| Received | Jun 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982215
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2016 | Ventlab LLC STAT-Check Resuscitation Bag
Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer
Intended for use in various clinical situations to provide respiratory support in the presence of rever Terminated |
CCK | None listed |
| Jul 3, 2014 | Ventlab LLC Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC81 Terminated |
BTM | None listed |
| Nov 1, 2012 | Ventlab Corporation Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 270 Terminated |
BTM | None listed |
| Jul 20, 2004 | Ventlab Corporation STAT-Check, Adult Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC 9000 Series, Ventlab Corporation, 155 Boyce Drive Terminated |
BTM | None listed |
| Jul 20, 2004 | Ventlab Corporation STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC-8000 Series, Ventlab Corporation, 155 Boyce D Terminated |
BTM | None listed |
| Jul 20, 2004 | Ventlab Corporation A.C.E. STAT-Check CO Indicator, Single, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order# SC200, Resuscitation ACE Corp., 155 Boyce Drive, Mocksville, NC 27028 Terminated |
BTM | None listed |
| Jul 20, 2004 | Ventlab Corporation STAT-Check Infant Disposable Manual Resuscitators, with 40 cmHO Pressure Limiting System & Pressure Port Adapter, Single Patient Use Non-Sterile, Re-Order SC7000 Series, Non Latex, Ventlab Corporation Terminated |
BTM | None listed |
| Jul 20, 2004 | Ventlab Corporation STAT-Check Infant Disposable Manual Resuscitators with Built-in Pressure Monitor, , with 40 cmHO Pressure Limiting System & Pressure Port Adapter, Single Patient Use, Non-Sterile, Re-Order SC7100 Seri Terminated |
BTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.