Vitalograph Ireland Ltd.
Co Clare Clare, IE
VITALOGRAPH IRELAND LTD. appears in FDA device records in Co Clare Clare, IE. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Vitalograph Ireland Ltd. between 2008 and 2023. The busiest year on record is 2015, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2020 | 2 |
| 2022 | 2 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223818 | Model 9160 VitaloQUB | JEH | Substantially Equivalent | |
| K221030 | Model 9100 PFT/DICO | BTY | Substantially Equivalent | |
| K212938 | Vitalograph Model 6000 Alpha | BZG | Substantially Equivalent | |
| K201562 | Spirotrac | BZG | Substantially Equivalent | |
| K200550 | Vitalograph Model 2120 In2itive eDiary | BZG | Substantially Equivalent | |
| K160253 | Vitalograph Model 6300 micro | BZG | Substantially Equivalent | |
| K142642 | Vitalograph Model 6600 Compact | BZG | Substantially Equivalent | |
| K142812 | Vitalograph Model 6800 Pneumotrac | BZG | Substantially Equivalent | |
| K141546 | VITALOGRAPH MODEL 7000 SPIROTRAC | BZG | Substantially Equivalent | |
| K110525 | VITALOGRAPH MODEL 7100 - VITALOJAK | DSH | Substantially Equivalent | |
| K100687 | VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 | BZG | Substantially Equivalent | |
| K073155 | VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) | BZG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002808458 | 3002808458 | VITALOGRAPH IRELAND LTD. | Gort Road Business Park, Co Clare Eire IE | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- BTYCalculator, Predicted Values, Pulmonary Function
- BXWCalibrator, Volume, Gas
- BXJClip, Nose
- BZHMeter, Peak Flow, Spirometry
- BYPMouthpiece, Breathing
- JEHPlethysmograph, Volume
- DSHRecorder, Magnetic Tape, Medical
- BZGSpirometer, Diagnostic
- BWFSpirometer, Therapeutic (Incentive)
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Vitalograph Ireland Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain