510(k) K010401 ยท MOD Accessory To Continuous Ventilator (Respirator)
TRI-PLEX ADAPTER
| Applicant | The Medical Device Group, Inc., Crofton MD, US |
| Decision | Substantially Equivalent, Oct 30, 2002 |
| Received | Feb 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010401
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2005 | Medical Device Group Inc. Tri-Plex Adapter, single unit (MD-04000 )or box of 25 (MD-04001) or case of 100 (MD-04002). Sterile. Single Use. Terminated |
MOD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.