FDA 510(k) Applications Submitted by HANNE NIELSEN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090406 |
02/17/2009 |
EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE |
INTERACOUSTICS AS |
| K151455 |
06/01/2015 |
3Shape Abutment Designer Software |
3Shape A/S |
| K141570 |
06/12/2014 |
IMPLANT STUDIO |
3SHAPE MEDICAL A/S |
| K161884 |
07/11/2016 |
Ortho System |
3Shape A/S |
| K152078 |
07/27/2015 |
Implant Studio 2015 |
3Shape Medical A/S |
| K152086 |
07/27/2015 |
3Shape Ortho System |
3Shape A/S |
| K042315 |
08/26/2004 |
CEREBRAL STATE MONITOR - CSM |
DANMETER A/S |
| K032954 |
09/22/2003 |
ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 |
DANMETER A/S |
| K032955 |
09/22/2003 |
AUTOMOVE, MODEL AM800 |
DANMETER A/S |
| K032988 |
09/24/2003 |
ELPHA 4 CONTI |
DANMETER A/S |
| K083861 |
12/24/2008 |
TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE |
INTERACOUSTICS AS |
| K163677 |
12/27/2016 |
Ortho System |
3Shape A/S |
|
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