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Vyaire 706572

by Jaeger Medical GmbH

Vyaire 706572 is a Class II device made by Jaeger Medical GmbH, cleared under FDA 510(k) K981366 on 30 Oct 1998 and listed in FDA GUDID since 24 May 2019 (UDI-DI 04250892905662), 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) K981366

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 Number04250892905662 UDI-DI Date24 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK981366 Date30 Oct 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K981366 decided 30 Oct 1998 Active
  • FDA GUDID UDI-DI 04250892905662 listed 24 May 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K981366
  2. Listed FDA GUDID 04250892905662

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vyaire
Generic name
Pulmonary function analysis system, adult
Model / Ref / Catalog
706572
Primary DI / UDI-DI
04250892905662
510(k) Number
FDA product code
BTY
GMDN term
Pulmonary function analysis system, adult
Device class
Class II
Regulation number
868.1890
GUDID distribution status
In Commercial Distribution

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Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)