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Hokanson 5.40

by D. E. Hokanson, Inc. 7 variants

Hokanson 5.40 (03416) is a Class II device made by D. E. Hokanson, Inc., cleared under FDA 510(k) K970570 on 3 Oct 1997 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00817065021525), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K970570

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817065021525 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK970570 Date3 Oct 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K970570 decided 3 Oct 1997 Active
  • FDA GUDID UDI-DI 00817065021525 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K970570
  2. Listed FDA GUDID 00817065021525

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hokanson
Generic name
Peripheral vascular haemodynamic measurement application software
Model / Ref / Catalog
5.40, 03416
Primary DI / UDI-DI
00817065021525
510(k) Number
FDA product code
DQK
GMDN term
Peripheral vascular haemodynamic measurement application software
Device class
Class II
Regulation number
870.1425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Peripheral vascular haemodynamic measurement application software

Cleared under the same submission (K970570)

and 3 more cleared under K970570

Similar devices

Other devices filed under FDA product code DQK (Computer, Diagnostic, Programmable).

Other devices from D. E. Hokanson, Inc.

See all devices from D. E. Hokanson, Inc. →

Properties

  • Serial number
Other properties (14, all answered No)