FDA 510(k) Applications Submitted by Kevin Howard
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080423 |
02/15/2008 |
INTEGRE, MODEL LP581 |
Ellex Medical Pty. Ltd. |
| K081565 |
06/04/2008 |
INTEGRE PRO, MODEL L2RY |
Ellex Medical Pty. Ltd. |
| K041598 |
06/14/2004 |
LASEREX, MODEL LP4532 |
Ellex Medical Pty. Ltd. |
| K172177 |
07/19/2017 |
Insulia Diabetes Management Companion |
Voluntis S.A. |
| K122202 |
07/25/2012 |
ELLEX 2RT |
Ellex Medical Pty. Ltd. |
| K232451 |
08/14/2023 |
Insulia Bolus Companion |
Voluntis SA. |
| K142398 |
08/27/2014 |
Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow |
Ellex Medical Pty. Ltd. |
| K202596 |
09/08/2020 |
Insulia Diabetes Management Companion |
Voluntis, S.A. |
| K052777 |
10/03/2005 |
LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D |
Ellex Medical Pty. Ltd. |
| K063352 |
11/06/2006 |
ELLEX SLIT LAMP, MODEL 30XL |
TAKAGI SEIKO CO., LTD. |
|
|
