Shape Medical Systems Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3008072932
• FEI Number: 3008072932
• Name: SHAPE MEDICAL SYSTEMS, INC
• Owner & Operator: Shape Medical Systems, Inc
• Contact Address: MedTech Center/Shape Medical Systems, In 5000 Township Parkway; Saint Paul MN 55110 US
• Official Correspondent:
  • Ravinder Diamond
  • x-651-6212990-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: MedTech Center/Shape Medical Systems, In 5000 Township Parkway; Saint Paul, MN 55110 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID B2009012 Shape Medical Systems, Inc.	Shape II System Refurbished	2022-04-22
GUDID B200HF012 SHAPE MEDICAL SYSTEMS, INC.	Shape	2019-05-10
GUDID B20083012 SHAPE MEDICAL SYSTEMS, INC.	Shape Vital Sign System	2019-05-10
GUDID B20044012 SHAPE MEDICAL SYSTEMS, INC.	Disposable Patient Interface with filter	2019-05-10
GUDID B200HF001 SHAPE MEDICAL SYSTEMS, INC.	Shape-HF	2018-07-06
GUDID B20089001 SHAPE MEDICAL SYSTEMS, INC.	Shape-HF	2018-07-06
GUDID B20044001 SHAPE MEDICAL SYSTEMS, INC.	Shape-HF	2018-07-06
GUDID B20040011 SHAPE MEDICAL SYSTEMS, INC.	Shape	2018-07-06
PMN K150888 | BTY SHAPE MEDICAL SYSTEMS, INC	Shape-HF DRR Testing system	2016-11-11
PMN K150888 SHAPE MEDICAL SYSTEMS, INC	Shape-HF Cardiopulmonary Testing System	2016-01-21
PMN K090722 | BTY SHAPE MEDICAL SYSTEMS, INC	SHAPE-HF	2009-07-10
PMN K090722 SHAPE MEDICAL SYSTEMS, INC	SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM	2009-03-31

Related Finance Registrations

NCAGE Code	6J2M9	SHAPE MEDICAL SYSTEMS, INC.
CAGE Code	6J2M9	SHAPE MEDICAL SYSTEMS, INC.
S.A.M. Registration	6J2M9 [21315587]	SHAPE MEDICAL SYSTEMS, INC.