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Hokanson EC6

by D. E. Hokanson, Inc. 2 variants

Hokanson EC6 (00537) is a Class II device made by D. E. Hokanson, Inc., cleared under FDA 510(k) K982707 on 26 Aug 1998 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00817065021280), 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) K982707

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 Number00817065021280 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK982707 Date26 Aug 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K982707 decided 26 Aug 1998 Active
  • FDA GUDID UDI-DI 00817065021280 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K982707
  2. Listed FDA GUDID 00817065021280

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  • Withdrawn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
Limb plethysmograph
Model / Ref / Catalog
EC6, 00537
Primary DI / UDI-DI
00817065021280
510(k) Number
FDA product code
JOM
GMDN term
Limb plethysmograph
Device class
Class II
Regulation number
870.2780
GUDID distribution status
In Commercial Distribution

Related devices

Category: Limb plethysmograph

Cleared under the same submission (K982707)

Similar devices

Other devices filed under FDA product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic).

Other devices from D. E. Hokanson, Inc.

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

Properties

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