Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022527636

FEI Number

3022527636

Entity Name

WAVELY DIAGNOSTICS, INC.

City/State/Country

Seattle, WA, US

Establishment Address

2319 North 45th Street, Suite 107, Seattle, WA 98103, US

Establishment Type(s)

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

Owner / Operator

Wavely Diagnostics, Inc. (Owner Number: 10085079)

Owner / Operator Contact Address

2319 North 45th Street, Suite 107, Seattle, WA 98103, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wavely Middle Ear Fluid Scanner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTO	Tester, Auditory Impedance, Exempt	Ear, Nose, Throat	Class 2	874.1090	2022-05-03

Official Correspondent

Carol Castillo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Wavely Diagnostics, Inc.

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 3022527636. Last updated year: 2026. Please use registration number 3022527636 when referencing this establishment in official correspondence.