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FDA 510(k)

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)

N.º K: K163667 · 2017-04-28

SolicitanteHealth Beacons, Inc.
Fecha de decisión2017-04-28
Código de productoPBY
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

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) is the device name listed in this FDA 510(k) record. The listed applicant is Health Beacons, Inc.. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K163667. The device is classified under product code PBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 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)?

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) is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Health Beacons, Inc.. The 510(k) number is K163667.

When did 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) receive FDA 510(k) clearance?

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) received FDA 510(k) clearance on 2017-04-28, under 510(k) number K163667.

Who is the listed applicant 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)?

The FDA 510(k) record lists Health Beacons, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code 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)?

The FDA product code 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) is PBY.

Ensayos clínicos relacionados

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Otros registros que enlistan a Health Beacons, Inc. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K193189RFID Localization SystemK190932RFID Localization SystemK181692Aplicador de Etiquetas de 5 cm, Aplicador de Etiquetas de 7 cm, Aplicador de Etiquetas de 10 cm, Aplicador de Etiquetas de 5 cm (paquete de 10), Aplicador de Etiquetas de 7 cm (paquete de 10), Aplicador de Etiquetas de 10 cm (paquete de 10), Probeta Quirúrgica LOCalizer, Probeta Quirúrgica LOCalizer (paquete de 5)

Dispositivos relacionados (Código: PBY)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K223682Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.K222643Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.K200734Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.K163541Magseed Magnetic Marker SystemEndomagnetics Ltd.,K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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