ANUMANA INC.

FDA Device Registration & Listing · Cambridge, MA, US · Registration 3029762850

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
3029762850
FEI Number
3029762850
Entity Name
ANUMANA INC.
City/State/Country
Cambridge, MA, US
Establishment Address
One Main Street, Suite 400, East Arcade, Cambridge, MA 02142, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Anumana Inc. (Owner Number: 10088820)
Owner / Operator Contact Address
One Main Street, Suite 400, East Arcade, Cambridge, MA 02142, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K250652
PMA Number
N/A

All Registered Proprietary Names

ECG-AI Low Ejection Fraction 12-Lead algorithm ECG-AI LEF 12-Lead algorithm

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QYE Reduced Ejection Fraction Machine Learning-Based Notification Software Cardiovascular Class 2 870.2380 2023-10-13
QYE Reduced Ejection Fraction Machine Learning-Based Notification Software Cardiovascular Class 2 870.2380 2025-11-17

Official Correspondent

Taylor Gold West

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Anumana Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029762850. Last updated year: 2026. Please use registration number 3029762850 when referencing this establishment in official correspondence.
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