510(k) K961029 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
KILTEX PROBE COVER
| Applicant | Kiltex Corp., Akron OH, US |
| Decision | Substantially Equivalent, Jul 25, 1996 |
| Received | Mar 14, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961029
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2017 | ECOLAB INC ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX.
To be used as a physical barrie Terminated |
IYO | None listed |
| Nov 22, 2017 | ECOLAB INC ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX.
To be used as a physical barrier Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.