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Hokanson

FDA UDI

Class II (US FDA UDI)

by D. E. Hokanson, Inc.

Identity

Trade Name
Hokanson FDA UDI
Generic Name
Peripheral vascular haemodynamic measurement application software FDA UDI
Device Name
ARTERIAL AND VENOUS EXAM SOFTWARE - 220 V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, a recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease in the patient. Includes interface box to connect computer to physiologic instruments and 220V mains. FDA UDI
Model / Reference
5.40 FDA UDI
Description
ARTERIAL AND VENOUS EXAM SOFTWARE - 220 V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, a recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease in the patient. Includes interface box to connect computer to physiologic instruments and 220V mains. FDA UDI

Identifiers

Catalog Number
03416 FDA UDI
Primary DI / UDI-DI
00817065021525 FDA UDI
510(k) Number
K970570 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Peripheral vascular haemodynamic measurement application software 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Peripheral vascular haemodynamic measurement application software

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

Similar devices

Also classified as Peripheral vascular haemodynamic measurement application software.

Cleared under the same submission

K970570 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
D. E. Hokanson, Inc.

Sources (1)

  • FDA UDI d6500cde-e82c-4242-8c97-79367456544e 36 fields · synced Jun 8, 2026