AGILEMD

FDA Device Registration & Listing · Cupertino, CA, US · Registration 3031823069

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
3031823069
FEI Number
3031823069
Entity Name
AGILEMD
City/State/Country
Cupertino, CA, US
Establishment Address
10080 N. Wolfe Rd., Suite SW3-229, Cupertino, CA 95014, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
AgileMD (Owner Number: 10091218)
Owner / Operator Contact Address
10080 N. Wolfe Rd., Suite SW3-229, Cupertino, CA 95014, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233253
PMA Number
N/A

All Registered Proprietary Names

eCARTv5 Clinical Deterioration Suite eCARTv5 eCART

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QNL Medium-Term Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2024-07-25

Official Correspondent

Borna Safabakhsh

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AgileMD
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 3031823069. Last updated year: 2026. Please use registration number 3031823069 when referencing this establishment in official correspondence.
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