Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2430863

FEI Number

2430863

Entity Name

AMBULATORY MONITORING, INC.

City/State/Country

ARDSLEY, NY, US

Establishment Address

731 SAW MILL RIVER RD., ARDSLEY, NY 10502, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

AMBULATORY MONITORING, INC. (Owner Number: 2430863)

Owner / Operator Contact Address

731 SAW MILL RIVER RD., --, Ardsley, NY 10502, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251574

PMA Number

N/A

All Registered Proprietary Names

Basic Respitrace System Motionlogger Actigraph Sleep Watch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2007-11-30
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2007-11-30
LEL	Device, Sleep Assessment	Neurology	Class 2	882.5050	2025-08-25

Official Correspondent

THOMAS KAZLAUSKY

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMBULATORY MONITORING, INC.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

Similar Registrations

Registration Number	Establishment Name	Location
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN
1219324	RESPIRONICS NOVAMETRIX, LLC	Andover, MA, US
3004415070	KB Components Finland Oy	Nurmijarvi Etela-Karjala, FI
3016490024	SENZIME AB	Uppsala, SE
3008729547	GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.	JUAREZ Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2430863. Last updated year: 2026. Please use registration number 2430863 when referencing this establishment in official correspondence.