FDA 510(k) Applications Submitted by DRTECH CORPORATION
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240243 |
01/30/2024 |
EConsole2 |
DRTECH Corporation |
| K170930 |
03/29/2017 |
RSM 2430C |
DRTECH Corporation |
| K171137 |
04/17/2017 |
EVS 2430W, EVS 2430GW |
DRTECH Corporation |
| K151942 |
07/14/2015 |
EVS 3643 |
DRTECH Corporation |
| K152172 |
08/04/2015 |
Econsole1 |
DRTECH CORPORATION |
| K142475 |
09/03/2014 |
EVS 4343 |
DRTECH Corporation |
| K192400 |
09/03/2019 |
EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG |
DRTECH Corporation |
| K162552 |
09/13/2016 |
EVS 3643, EVS 3643G |
DRTECH Corporation |
| K162555 |
09/13/2016 |
EVS 4343, EVS 4343G |
DRTECH CORPORATION |
| K162670 |
09/26/2016 |
RSM 1824C with RConsole1 |
DRTECH CORPORATION |
| K193031 |
10/30/2019 |
EXPD 4343P, EXPD 3643P |
DRTECH Corporation |
| K223124 |
10/03/2022 |
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG |
DRTECH Corporation |
| K242847 |
09/20/2024 |
EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi |
DRTECH Corporation |
| K243443 |
11/06/2024 |
EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP |
DRTECH Corporation |
| K231225 |
04/28/2023 |
EConsole1 |
DRTECH Corporation |
| K233530 |
11/02/2023 |
EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi |
DRTECH Corporation |
| K230871 |
03/30/2023 |
EXTRON 5; EXTRON 7 |
DRTECH Corporation |
| K232753 |
09/08/2023 |
EXPD 4343D; EXPD 3643D |
DRTECH Corporation |
| K232082 |
07/13/2023 |
EXPD 4343S |
DRTECH Corporation |
| K231959 |
07/03/2023 |
EXPD 4357; EXPD 4357P |
DRTECH Corporation |
| K250010 |
01/02/2025 |
EXTRON 3; EXTRON 5; EXTRON 7 |
DRTECH Corporation |
| K193017 |
10/29/2019 |
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP |
DRTECH Corporation |
| K220073 |
01/10/2022 |
RMF-2000 |
DRTECH Corporation |
| K242591 |
08/30/2024 |
XERO-alpha |
DRTECH Corporation |
| K242770 |
09/13/2024 |
EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG |
DRTECH Corporation |
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