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 |