510(k) K092713 ยท IZL System, X-Ray, Mobile
SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM
| Applicant | Transamerican Medical Imaging, Lindon UT, US |
| Decision | Substantially Equivalent, Jul 16, 2010 |
| Received | Sep 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092713
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2014 | Trans American Medical, Inc. Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB.
The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use wi Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.