510(k) K163667 ยท PBY Temporary Tissue Marker
RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)
| Applicant | Health Beacons, Inc., Concord MA, US |
| Decision | Substantially Equivalent, Apr 28, 2017 |
| Received | Dec 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163667
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.