The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Selectrode.
| Device ID | K894920 |
| 510k Number | K894920 |
| Device Name: | SELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Contact | Povlsen |
| Correspondent | Povlsen S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-02 |
| Decision Date | 1989-10-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SELECTRODE 90273982 not registered Live/Pending |
Drew Marine USA, Inc. 2020-10-23 |
![]() SELECTRODE 72394927 0946300 Dead/Expired |
RADIOMETER A/S 1971-06-15 |
![]() SELECTRODE 72128330 0735594 Dead/Expired |
BERKELEY-DAVIS, INC. 1961-09-21 |