The following data is part of a premarket notification filed by Health Beacons, Inc. with the FDA for 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).
| Device ID | K163667 |
| 510k Number | K163667 |
| Device Name: | 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) |
| Classification | Temporary Tissue Marker |
| Applicant | HEALTH BEACONS, INC. 34 WALDEN STREET #753 Concord, MA 01742 |
| Contact | Nancy Confrey |
| Correspondent | Nancy Confrey HEALTH BEACONS, INC. 34 WALDEN STREET #753 Concord, MA 01742 |
| Product Code | PBY |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-27 |
| Decision Date | 2017-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10855436007065 | K163667 | 000 |
| 10855436007058 | K163667 | 000 |
| 10855436007041 | K163667 | 000 |
| 00855436007037 | K163667 | 000 |
| 10855436007027 | K163667 | 000 |
| 10855436007010 | K163667 | 000 |