Variosystems Ag

FDA Filings

This page includes the latest FDA filings for Variosystems Ag. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003318787
• FEI Number: 3003318787
• Name: Welker
• Owner & Operator: Variosystems AG
• Contact Address: Amperestr. 5 ; Steinach CH-SG Sankt Gallen 9323 CH
• Official Correspondent:
  • Johannes Sicher
  • 041-71-4478700-x
• US Agent:
  • Welker
  • Variosystems Inc.
  • 817 5523366
  • 817 4167436
  • A.Welker@variosystems.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 901 S KIMBALL AVE ; SOUTHLAKE, TX 76092 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K161536 | BZG Welker [Variosystems AG]	EasyOne Air Spirometer	2018-07-12
PMN K161534 | BTY Welker [Variosystems AG]	EasyOne Pro/Pro LAB	2018-07-12
PMN K120635 | BTY Welker [Variosystems AG]	EasyOne Pro LAB	2018-07-12
PMN K091428 | BTY Welker [Variosystems AG]	EasyOne Pro	2018-07-12
PMN K090034 | BZG Welker [Variosystems AG]	Easy on-PC Spirometer	2018-07-12