The following data is part of a premarket notification filed by Electramold with the FDA for Electrode.
Device ID | K050248 |
510k Number | K050248 |
Device Name: | ELECTRODE |
Classification | Electrode, Electrocardiograph |
Applicant | ELECTRAMOLD 3600 CHAMBERLAIN LANE SUITE 356 Louisville, KY 40241 -1914 |
Contact | E.w. Johnson |
Correspondent | E.w. Johnson ELECTRAMOLD 3600 CHAMBERLAIN LANE SUITE 356 Louisville, KY 40241 -1914 |
Product Code | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-02-03 |
Decision Date | 2005-05-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00868795000250 | K050248 | 000 |
00868795000243 | K050248 | 000 |
00868795000236 | K050248 | 000 |
00868795000229 | K050248 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ELECTRODE 87012659 not registered Live/Pending |
Wal-Mart Stores, Inc 2016-04-25 |
![]() ELECTRODE 87012643 not registered Live/Pending |
Wal-Mart Stores, Inc 2016-04-25 |
![]() ELECTRODE 85132625 not registered Dead/Abandoned |
Ball, Michael 2010-09-17 |