The following data is part of a premarket notification filed by Health Beacons, Inc. with the FDA for Rfid Localization System.
| Device ID | K190932 |
| 510k Number | K190932 |
| Device Name: | RFID Localization System |
| Classification | Marker, Radiographic, Implantable |
| Applicant | Health Beacons, Inc. 34 Walden St. #753 Concord, MA 01742 |
| Contact | Nancy Confrey |
| Correspondent | Carol Vierling R&Q Solutions 2790 Mosside Blvd, Suite 800 Monroeville, PA 15146 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-10 |
| Decision Date | 2019-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10855436007140 | K190932 | 000 |
| 10855436007133 | K190932 | 000 |
| 10855436007126 | K190932 | 000 |