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Hokanson MD35

by D. E. Hokanson, Inc. 3 variants

Hokanson MD35 (00496) is a Class II device made by D. E. Hokanson, Inc., cleared under FDA 510(k) K896034 on 18 Jan 1990 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00817065021389), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K896034

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 Number00817065021389 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK896034 Date18 Jan 1990DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K896034 decided 18 Jan 1990 Active
  • FDA GUDID UDI-DI 00817065021389 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K896034
  2. Listed FDA GUDID 00817065021389

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  • Withdrawn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
Noninvasive vascular ultrasound system, line-powered
Model / Ref / Catalog
MD35, 00496
Primary DI / UDI-DI
00817065021389
510(k) Number
FDA product code
DSB
GMDN term
Noninvasive vascular ultrasound system, line-powered
Device class
Class II
Regulation number
870.2770
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K896034)

and 2 more cleared under K896034

Similar devices

Other devices filed under FDA product code DSB (Plethysmograph, Impedance).

Other devices from D. E. Hokanson, Inc.

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

Properties

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