Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006777109

FEI Number

3006777109

Entity Name

OXYHEALTH, LLC

City/State/Country

Santa Fe Springs, CA, US

Establishment Address

10719 Norwalk Blvd, Santa Fe Springs, CA 90670, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

OxyHealth, LLC (Owner Number: 10031555)

Owner / Operator Contact Address

10719 Norwalk Blvd, Santa Fe Springs, CA 90670, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K001409

PMA Number

N/A

All Registered Proprietary Names

Fortius 420 EXP Fortius 420 Quamvis 320 Vitaeris 320 Solace 210 Respiro 270

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBF	Chamber, Hyperbaric	Anesthesiology	Class 2	868.5470	2010-02-12
CBF	Chamber, Hyperbaric	Anesthesiology	Class 2	868.5470	2023-10-04

Official Correspondent

Mayur Patel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OxyHealth, LLC

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 3006777109. Last updated year: 2026. Please use registration number 3006777109 when referencing this establishment in official correspondence.