Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029984080

FEI Number

3029984080

Entity Name

SPARK NEURO, INC.

City/State/Country

New York, NY, US

Establishment Address

224 W 35th St Ste 500 # 2031, New York, NY 10001, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Spark Neuro, Inc. (Owner Number: 10089104)

Owner / Operator Contact Address

212 W. 18th Street, 17a, New York, NY 10011, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPARK Neuro Cognitive Assessment Aid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTY	Computerized Cognitive Assessment Aid, Exempt	Neurology	Class 2	882.1470	2023-11-06

Official Correspondent

Marinela Gombosev

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spark Neuro, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3043617526	AD SCIENTIAM	Paris Ile-de-France, FR
3033273494	NEUROTONE AI, INC	Gainesville, FL, US
3032027298	Kneu Health Limited	London London, City of, GB
3026751369	NEUROWYZR PTE LTD.	Singapore Central Singapore, SG
3035679498	NEOTIV GMBH	Magdeburg Saxony-Anhalt, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029984080. Last updated year: 2026. Please use registration number 3029984080 when referencing this establishment in official correspondence.