FDA 510(k) Applications Submitted by TOVE KJAER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K010130 |
01/16/2001 |
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
| K000386 |
02/07/2000 |
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
| K140317 |
02/10/2014 |
EMBRYOGEN |
ORIGIO A/S |
| K011471 |
05/14/2001 |
BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
| K011472 |
05/14/2001 |
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
| K161547 |
06/03/2016 |
Transem and EchoGen Embryo Transfer Catheters |
ORIGIO A/S |
| K172197 |
07/21/2017 |
SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS |
ORIGIO a/s |
| K002992 |
09/25/2000 |
DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
| K152932 |
10/05/2015 |
BlastGen |
ORIGIO A/S |
| K133387 |
11/05/2013 |
ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED |
ORIGIO A/S |
| K153267 |
11/12/2015 |
ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash |
ORIGIO A/S |
| K173624 |
11/24/2017 |
ORIGIO« HandlingÖ without phenol red (Cat. No. 8310), ORIGIO« HandlingÖ with phenol red (Cat. No. 8311) |
Origio a/s |
| K133707 |
12/04/2013 |
SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS |
ORIGIO A/S |
| K173731 |
12/06/2017 |
SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) |
CooperSurgical, Inc |
| K133912 |
12/23/2013 |
ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO |
ORIGIO A/S |
| K014269 |
12/27/2001 |
POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
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