SHAPE MEDICAL SYSTEMS, INC

FDA Device Registration & Listing · Saint Paul, MN, US · Registration 3008072932

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008072932
FEI Number
3008072932
Entity Name
SHAPE MEDICAL SYSTEMS, INC
City/State/Country
Saint Paul, MN, US
Establishment Address
MedTech Center/Shape Medical Systems, In, 5000 Township Parkway, Saint Paul, MN 55110, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shape Medical Systems, Inc (Owner Number: 10029892)
Owner / Operator Contact Address
MedTech Center/Shape Medical Systems, In, 5000 Township Parkway, Saint Paul, MN 55110, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K090722
PMA Number
N/A

All Registered Proprietary Names

Shape-HF DRR Testing system SHAPE-HF

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BTY Calculator, Predicted Values, Pulmonary Function Anesthesiology Class 2 868.1890 2016-11-11
BTY Calculator, Predicted Values, Pulmonary Function Anesthesiology Class 2 868.1890 2009-07-10

Official Correspondent

Brant Newman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Shape Medical Systems, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008072932. Last updated year: 2026. Please use registration number 3008072932 when referencing this establishment in official correspondence.
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