510(k) K062610 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
CARE-E-VAC 3
| Applicant | Ohio Medical Corporation, Gurnee IL, US |
| Decision | Substantially Equivalent, Sep 28, 2006 |
| Received | Sep 5, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062610
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2018 | Ohio Medical Corporation Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC
The care-e-(R)3 is a portable medical aspirator used to suction Terminated |
BTA | None listed |
| Dec 29, 2010 | Ohio Medical Corporation Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 758000
The device is a portable aspirator to help evacuate saliva, Terminated |
BTA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.