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Hokanson AG101

by D. E. Hokanson, Inc. 2 variants

Hokanson AG101 (00584) is a medical device air compressor (FDA Class II; FDA product code DXN, System, Measurement, Blood-Pressure, Non-Invasive) made by D. E. Hokanson, Inc., cleared under FDA 510(k) K905367 on 6 Mar 1991 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00817065021235), 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) K905367

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 Number00817065021235 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK905367 Date6 Mar 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K905367 decided 6 Mar 1991 Active
  • FDA GUDID UDI-DI 00817065021235 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K905367
  2. Listed FDA GUDID 00817065021235

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  • Withdrawn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
Medical device air compressor
Model / Ref / Catalog
AG101, 00584
Primary DI / UDI-DI
00817065021235
510(k) Number
FDA product code
DXN
GMDN term
Medical device air compressor
Device class
Class II
Regulation number
870.1130
GUDID distribution status
In Commercial Distribution

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Other devices filed under Medical device air compressor.

Other devices from D. E. Hokanson, Inc.

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Properties

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