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)— 510(k) K163667
Substantially EquivalentHealth Beacons, Inc.
FDA 510(k) clearance K163667 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), Substantially Equivalent on 2017-04-28. Applicant: Health Beacons, Inc.. Device class: 2.
Clearance details
- Applicant
- Health Beacons, Inc.
- Product code
- Code PBY
- 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 PBY
view all- K223682 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
- K222643 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
- K200734 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
- K163541 — Magseed Magnetic Marker System
- K153044 — Sentimag System, Sentimark Magnetic Marker Systerm
More clearances from Health Beacons, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.