Aclarion, Inc.

FDA Device Registration & Listing · Broomfield, CO, US · Registration 3015426626

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
3015426626
FEI Number
3015426626
Entity Name
Aclarion, Inc.
City/State/Country
Broomfield, CO, US
Establishment Address
8181 Arista Place, Ste 100, Broomfield, CO 80021, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Aclarion, Inc. (Owner Number: 10059751)
Owner / Operator Contact Address
8181 Arista Place, Suite 100, Broomfield, CO 80021, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NOCICALC-LS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2019-02-19

Official Correspondent

James Abel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K781173 Instrumentation Laboratory CO COMPUTER INTERFACE IL 814 1978-09-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-04 Misys Healthcare Systems 1
Calculator/Data Processing Module for Clinical Use
Z-0026-2025 Becton Dickinson & Co. 1
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015426626. Last updated year: 2026. Please use registration number 3015426626 when referencing this establishment in official correspondence.
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