510(k) K123957 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
PNEUPAC PARAPAC PLUS
| Applicant | Smiths Medical International , Ltd., Luton, Bedfordshire, GB |
| Decision | Substantially Equivalent, Sep 16, 2013 |
| Received | Dec 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123957
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2024 | Smiths Medical ASD Inc. paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N Open, Classified |
BTL | None listed |
| Sep 20, 2024 | Smiths Medical ASD Inc. paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N Open, Classified |
BTL | None listed |
| Sep 11, 2024 | Smiths Medical ASD Inc. Pneupac paraPAC plus 300 ventilator kit, REF P300NXX Open, Classified |
BTL | None listed |
| Sep 11, 2024 | Smiths Medical ASD Inc. Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX Open, Classified |
BTL | None listed |
| Mar 19, 2024 | Smiths Medical ASD Inc. smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS Open, Classified |
BTL | None listed |
| Mar 19, 2024 | Smiths Medical ASD Inc. smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS Open, Classified |
BTL | None listed |
| Jul 15, 2021 | Smiths Medical ASD Inc. Pneupac paraPac plus 300 ventilator kit, REF P300NGB Terminated |
BTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.