Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002808458

FEI Number

3002808458

Entity Name

VITALOGRAPH IRELAND LTD.

City/State/Country

Co Clare, IE

Establishment Address

Gort Road Business Park, Ennis, Co Clare Eire, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Vitalograph Ireland Ltd. (Owner Number: 10024235)

Owner / Operator Contact Address

Gort Road Business Park, Ennis, Co Clare, IE-CE V95 HFT4, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190568

PMA Number

N/A

All Registered Proprietary Names

Compas aerosol inhalation monitor {AIM} Vitalograph Model 4500 Vitalograph Nose Clip Vitalograph Model 2030 Alpha Spirotrac 6 VITALOGRAPH MODEL 7100 - Cough Monitor VITALOGRAPH MODEL 7100 - VITALOJAK Model 6300 micro BT12 ECG Model 7000 Spirotrac PFT Equipment ComPas2 Vitalograph Model 4000 Vitalograph Model 2120 In2itive e-Diary Vitalograph Model 2120 In2itive Vitalograph Model 6800 Pneumotrac Vitalograph PFM {Peak Flow Meter} Vitalograph Model 4300 Compas

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2024-12-04
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2008-01-14
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2011-09-09
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2022-01-28
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2020-12-18
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2012-01-31
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2016-08-26
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2018-03-09
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2014-09-19
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2022-07-18
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2024-12-04
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2008-12-11
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2010-12-20
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2015-08-28
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2008-01-14
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2024-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

Chris McKinney Business: Vitalograph Inc Email: chris.mckinney@vitalograph.com Phone: (913) 7303207

Related Public Records

Same Entity

Vitalograph Ireland Ltd.

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
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
K820986	Dart Medical Equipment	EKG MONITORS, VARIOUS MODELS	1982-04-29
K910450	Medtech Industries, Inc.	CARD GUARD-3000 ECG TELEPHONE ADAPTER	1991-05-07
K761318	Cambridge Instruments, Inc.	3038 OPTION B-COMPUT. TRANS. TERMINAL	1977-01-06
K972649	Reynolds Medical , Ltd.	CARDIOCALL CARDIAC EVENT RECORDER	1997-12-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002808458. Last updated year: 2026. Please use registration number 3002808458 when referencing this establishment in official correspondence.