Hokanson

FDA UDI

Class II (US FDA UDI)

by D. E. Hokanson, Inc.

Identity

Trade Name: Hokanson FDA UDI
Generic Name: Medical networking interface unit FDA UDI
Device Name: SOFTWARE INTERFACE BOX - An electrically-powered hardwired interface between one or multiple physiologic devices and a connected computer with dedicated physiologic software. The interface receives waveform and pressure data and formats the data before sending it to the computer. The interface also receives signals from the computer to activate a connected physiologic device. The device does not store data after it is sent to the computer. FDA UDI
Model / Reference: IB4 FDA UDI
Description: SOFTWARE INTERFACE BOX - An electrically-powered hardwired interface between one or multiple physiologic devices and a connected computer with dedicated physiologic software. The interface receives waveform and pressure data and formats the data before sending it to the computer. The interface also receives signals from the computer to activate a connected physiologic device. The device does not store data after it is sent to the computer. FDA UDI

Identifiers

Catalog Number: 00725 FDA UDI
Primary DI / UDI-DI: 00817065021174 FDA UDI
510(k) Number: K970570 FDA UDI
FDA Product Code: DQK FDA UDI
GMDN Term: Medical networking interface unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1425 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

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

FDA UDI

Category: Medical networking interface unit

Hokanson by D. E. Hokanson, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K970570 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: D. E. Hokanson, Inc.

Sources (1)

FDA UDI a6b6ea6b-b8db-4474-9236-f8ab6f0f630b 36 fields · synced Jun 8, 2026