RFID Localization System— 510(k) K190932
Substantially EquivalentHealth Beacons, Inc.
FDA 510(k) clearance K190932 for RFID Localization System, Substantially Equivalent on 2019-09-13. Applicant: Health Beacons, Inc.. Device class: 2.
Clearance details
- Applicant
- Health Beacons, Inc.
- Product code
- Code NEU
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Concord, MA, US
Recent devices under product code NEU
view allMore clearances from Health Beacons, Inc.
view all- K193189 — RFID Localization System
- K181692 — 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack)
- K163667 — 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)
Adverse events under product code NEU
product code NEU- Injury
- 824
- Total
- 824
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.