Company ยท IE
Vitalograph (Ireland) , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2023. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 25, 2023 | K223818 | Model 9160 VitaloQUB Vitalograph Ireland, Ltd., IE | JEH |
| Jul 15, 2022 | K221030 | Model 9100 PFT/DICO Vitalograph Ireland, Ltd., IE | BTY |
| Jan 26, 2022 | K212938 | Vitalograph Model 6000 Alpha Vitalograph Ireland, Ltd., IE | BZG |
| Oct 14, 2020 | K201562 | Spirotrac Vitalograph Ireland, Ltd., IE | BZG |
| Jul 27, 2020 | K200550 | Vitalograph Model 2120 In2itive eDiary Vitalograph Ireland, Ltd., IE | BZG |
| Aug 26, 2016 | K160253 | Vitalograph Model 6300 micro Vitalograph (Ireland) , Ltd., IE | BZG |
| Jun 30, 2015 | K142642 | Vitalograph Model 6600 Compact Vitalograph (Ireland) , Ltd., IE | BZG |
| Jun 29, 2015 | K142812 | Vitalograph Model 6800 Pneumotrac Vitalograph (Ireland) , Ltd., IE | BZG |
| Sep 3, 2014 | K141546 | VITALOGRAPH MODEL 7000 SPIROTRAC Vitalograph (Ireland) , Ltd., IE | BZG |
| Nov 23, 2011 | K110525 | VITALOGRAPH MODEL 7100 - VITALOJAK Vitalograph (Ireland) , Ltd., IE | DSH |
| Oct 16, 2010 | K100687 | VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 Vitalograph (Ireland) , Ltd., IE | BZG |
| Jun 4, 2008 | K073155 | VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) Vitalograph (Ireland) , Ltd., IE | BZG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||