Vitalograph (Ireland) , Ltd. is one of 55 FDA 510(k) medical device manufacturers from Ireland in the dataset, ranked by real submission volume.
Vitalograph (Ireland) , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Model 9160 VitaloQUB, Model 9100 PFT/DICO, Vitalograph Model 6000 Alpha
12
Total
12
Cleared
0
Denied
Vitalograph (Ireland) , Ltd. has 12 FDA 510(k) cleared anesthesiology devices. Based in Ennis, Co. Clare, IE.
Last cleared in 2023. Active since 2008.
Browse the complete list of FDA 510(k) cleared anesthesiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Vitalograph Ireland Ltd. C/O Promedic, LLC, ProMedic, LLC and ProMedic Consulting, LLC.
FDA 510(k) Regulatory Record - Vitalograph (Ireland) , Ltd.
12 devices
Cleared
May 25, 2023
Model 9160 VitaloQUB
Anesthesiology
155d
Cleared
Jul 15, 2022
Model 9100 PFT/DICO
Anesthesiology
99d
Cleared
Jan 26, 2022
Vitalograph Model 6000 Alpha
Anesthesiology
133d
Cleared
Oct 14, 2020
Spirotrac
Anesthesiology
126d
Cleared
Jul 27, 2020
Vitalograph Model 2120 In2itive eDiary
Anesthesiology
146d
Cleared
Aug 26, 2016
Vitalograph Model 6300 micro
Anesthesiology
207d
Cleared
Jun 30, 2015
Vitalograph Model 6600 Compact
Anesthesiology
286d
Cleared
Jun 29, 2015
Vitalograph Model 6800 Pneumotrac
Anesthesiology
273d
Cleared
Sep 03, 2014
VITALOGRAPH MODEL 7000 SPIROTRAC
Anesthesiology
85d
Cleared
Nov 23, 2011
VITALOGRAPH MODEL 7100 - VITALOJAK
Cardiovascular
273d
Cleared
Oct 16, 2010
VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120
Anesthesiology
220d
Cleared
Jun 04, 2008
VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
Anesthesiology
209d