Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021974922

FEI Number

3021974922

Entity Name

Vitasora Health Limited

City/State/Country

Melbourne Victoria, AU

Establishment Address

Suite 1, Level 9, 432 St Kilda Road, Melbourne Victoria 3004, AU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Vitasora Health Limited (Owner Number: 10084368)

Owner / Operator Contact Address

Suite 1, Level 9, 432 St Kilda Road, Melbourne, AU-VIC 3004, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202062

PMA Number

N/A

All Registered Proprietary Names

wheezo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PHZ	Abnormal Breath Sound Device	Anesthesiology	Class 2	868.1900	2022-02-14

Official Correspondent

Peter Hildebrandt

US Agent Details

Peter Hildebrandt Business: Vitasora Health USA, Inc. Email: peter@vitasorahealth.com Phone: (213) 3066866

Related Public Records

Same Entity

Vitasora Health Limited

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 3021974922. Last updated year: 2026. Please use registration number 3021974922 when referencing this establishment in official correspondence.