Spirosure Inc

FDA Filings

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

FDA Registration(s)
Registration Number3013216353
FEI Number3013216353
NameSPIROSURE, INC.
Owner & OperatorSpirosure, Inc.
Contact Address7020 Koll Center Parkway, Suite 110
Pleasanton CA 94566 US
Official Correspondent
  • Ryan Leard
  • 1-510-2073860-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7020 KOLL CENTER PKWY STE 110
Pleasanton, CA 94566 US
Establishment Type
  • Manufacture Device in the United States for Export Only
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
SPIROSURE, INC.
Fenom Pro2019-05-28
Spirosure, Inc.
Fenom Pro Nitric Oxide Test2019-02-13
SPIROSURE, INC.
Fenom2018-08-15

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