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Alpha 6000

by Vitalograph Ireland, Ltd. 47 variants

Alpha 6000 is a Class II device made by Vitalograph Ireland, Ltd., cleared under FDA 510(k) K873562 on 29 Aug 1988 and listed in FDA GUDID since 29 Apr 2017 (UDI-DI 15099169650128), 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) K873562

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 Number15099169650128 UDI-DI Date29 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK873562 Date29 Aug 1988DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K873562 decided 29 Aug 1988 Active
  • FDA GUDID UDI-DI 15099169650128 listed 29 Apr 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K873562
  2. Listed FDA GUDID 15099169650128

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Alpha
Generic name
Diagnostic spirometer, professional
Model / reference
6000
Primary DI / UDI-DI
15099169650128
510(k) Number
FDA product code
BZG
GMDN term
Diagnostic spirometer, professional
Device class
Class II
Regulation number
868.1840
GUDID distribution status
In Commercial Distribution

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Properties

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