510(k) K093913 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
MERCURY MEDICAL T-PIECE RESUSCITATOR
| Applicant | Mercury Medical, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Apr 6, 2010 |
| Received | Dec 22, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093913
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Mercury Enterprises, Inc. dba Mercury Medical Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842 Open, Classified |
BTL | None listed |
| Oct 2, 2024 | Mercury Enterprises, Inc. dba Mercury Medical Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support. Open, Classified |
BTL | None listed |
| Oct 22, 2015 | Mercury Enterprises, Inc. dba Mercury Medical Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit.
The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of Terminated |
BTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.