510(k) K964815 ยท LLN Device, Vibration Threshold Measurement
AP-4000, AIR PULSE SENSORY STIMULATOR
| Applicant | Pentax Precision Instrument Corp., Miramar FL, US |
| Decision | Substantially Equivalent, Sep 4, 1997 |
| Received | Nov 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964815
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.