Hokanson

FDA UDI

Class II (US FDA UDI)

by D. E. Hokanson, Inc.

Identity

Trade Name: Hokanson FDA UDI
Generic Name: Paper chart recorder FDA UDI
Device Name: CHART RECORDER - A portable chart recorder used with several physiologic testing devices. Recorder prints waveforms in real time from any of the attached instruments. Plays audio signals if produced by the attached instrument. The recorder has a rechargeable internal battery. FDA UDI
Model / Reference: MD6VR FDA UDI
Description: CHART RECORDER - A portable chart recorder used with several physiologic testing devices. Recorder prints waveforms in real time from any of the attached instruments. Plays audio signals if produced by the attached instrument. The recorder has a rechargeable internal battery. FDA UDI

Identifiers

Catalog Number: 00830 FDA UDI
Primary DI / UDI-DI: 00817065021372 FDA UDI
510(k) Number: K901592 FDA UDI
FDA Product Code: DXK FDA UDI
GMDN Term: Paper chart recorder FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2330 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: Paper chart recorder

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

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Chart, X-Ref Ohio Med 617-0020-300, 5" x 200', 8L — A-M Systems, Inc. · Class I

Cleared under the same submission

K901592 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 b159d716-0875-46d4-a3ca-b7324b0879b2 36 fields · synced Jun 8, 2026