510(k) K163313 ยท ITX Transducer, Ultrasonic, Diagnostic
ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor
| Applicant | CIVCO Medical Instruments Co., Inc., Deep River CT, US |
| Decision | Substantially Equivalent, Jun 9, 2017 |
| Received | Nov 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163313
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.