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AdviewII™ 9005-12XBD-1MB

by American Diagnostic Corporation

AdviewII™ 9005-12XBD-1MB is a Class II device made by American Diagnostic Corporation, cleared under FDA 510(k) K160439 on 6 Jul 2016 and listed in FDA GUDID since 27 Apr 2018 (UDI-DI 00634782085377), active as of 23 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 23 Oct 2026

Documents

510(k) K160439

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00634782085377 UDI-DI Date27 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK160439 Date6 Jul 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160439 decided 6 Jul 2016 Active
  • FDA GUDID UDI-DI 00634782085377 listed 27 Apr 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160439
  2. Listed FDA GUDID 00634782085377

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AdviewII™
Generic name
Automatic-inflation electronic sphygmomanometer, non-portable
Model / Ref / Catalog
9005-12XBD-1MB
Primary DI / UDI-DI
00634782085377
510(k) Number
FDA product code
DXN
GMDN term
Automatic-inflation electronic sphygmomanometer, non-portable
Device class
Class II
Regulation number
870.1130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Automatic-inflation electronic sphygmomanometer, non-portable

Cleared under the same submission (K160439)

and 8 more cleared under K160439

Similar devices

Other devices filed under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Other devices from American Diagnostic Corporation

See all devices from American Diagnostic Corporation →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)