Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032906215

FEI Number

3032906215

Entity Name

HUXLEY MEDICAL

City/State/Country

Atlanta, GA, US

Establishment Address

1465 Northside Dr Nw Ste 217, Atlanta, GA 30318, US

Establishment Type(s)

Remanufacture Medical Device,Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Huxley Medical (Owner Number: 10091588)

Owner / Operator Contact Address

1465 Northside Dr. NW, Suite 217, Atlanta, GA 30318, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240285

PMA Number

N/A

All Registered Proprietary Names

SANSA SANSA SANSA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2025-12-09
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2025-12-09
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2025-12-09
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2025-12-09
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2025-12-09
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2024-10-17
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2024-10-17

Official Correspondent

Daniel Burnham

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Huxley Medical

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02
K913749	Edentec Corp.	EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170	1992-07-02
K771407	Research Development Corp.	LUNG VOLUME & PRESSURE MONITOR	1977-08-04
K122223	Philips Medizin Systeme Boeblingen GmbH	NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO	2013-04-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032906215. Last updated year: 2026. Please use registration number 3032906215 when referencing this establishment in official correspondence.