Wireless Remote Control

FDA UDI

Class II (US FDA UDI)

by Bk Medical ApS

Identity

Trade Name: Wireless Remote Control FDA UDI
Generic Name: Diagnostic radiography device remote control FDA UDI
Device Name: Wireless Remote Control for bk3000 and bk5000 FDA UDI
Model / Reference: UA2361 FDA UDI
Description: Wireless Remote Control for bk3000 and bk5000 FDA UDI

Identifiers

Primary DI / UDI-DI: 05704916000318 FDA UDI
510(k) Number: K223830 FDA UDI
FDA Product Code: ITX FDA UDI
GMDN Term: Diagnostic radiography device remote control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic radiography device remote control

Wireless Remote Control by Bk Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic radiography device remote control.

RC-115 — Source-Ray, Inc. · Class II
Wireless Remote Control — Bk Medical ApS · Class II

Cleared under the same submission

K223830 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bk Medical ApS

Sources (1)

FDA UDI 0a96be3e-fee8-4b8e-8322-ba473348ad4b 35 fields · synced May 30, 2026