Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034603436

FEI Number

3034603436

Entity Name

LEVEL 42 AI, INC

City/State/Country

Santa Clara, CA, US

Establishment Address

Niterra Venture Lab, 3979 Freedom Cir # 401, Santa Clara, CA 95054, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

https://www.level42.ai/ (Owner Number: 10092200)

Owner / Operator Contact Address

211 Hope Street, Suite 391049, Mountain View, CA 94041, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

imPulse® UNA Warden+ imPulse® Whisper Vibrome Probe Cicerone Warden Vibrome nCoder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQC	Phonocardiograph	Cardiovascular	Class 1	870.2390	2024-12-12

Official Correspondent

SHASHA JUMBE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

https://www.level42.ai/

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 3034603436. Last updated year: 2026. Please use registration number 3034603436 when referencing this establishment in official correspondence.