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Diagnostix™ 9000TOP

by American Diagnostic Corporation

Diagnostix™ 9000TOP is a Class II device made by American Diagnostic Corporation, cleared under FDA 510(k) K070750 on 2 May 2007 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00634782065034), 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) K070750

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 Number00634782065034 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK070750 Date2 May 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070750 decided 2 May 2007 Active
  • FDA GUDID UDI-DI 00634782065034 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K070750
  2. Listed FDA GUDID 00634782065034

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Diagnostix™
Generic name
Automatic-inflation electronic sphygmomanometer, non-portable
Model / Ref / Catalog
9000TOP
Primary DI / UDI-DI
00634782065034
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 (K070750)

and 8 more cleared under K070750

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
  • Manufacturing date
Other properties (12, all answered No)