510(k) K952080 ยท GWJ Stimulator, Auditory, Evoked Response
CLARITY SYSTEM II
| Applicant | Sonamed Corp., Weston MA, US |
| Decision | Substantially Equivalent, Sep 19, 1995 |
| Received | May 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952080
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2010 | Natus Medical Inc SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154 Terminated |
GWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.