510(k) K061205 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR
| Applicant | Medela AG, Baar Zug, CH |
| Decision | Substantially Equivalent, Jun 21, 2006 |
| Received | May 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061205
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2008 | Medtronic Neuromodulation Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum Terminated |
BTA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.