The following data is part of a premarket notification filed by Ndm Corp. with the FDA for V-trace Ecg Backpad.
Device ID | K761301 |
510k Number | K761301 |
Device Name: | V-TRACE ECG BACKPAD |
Classification | Electrode, Electrocardiograph |
Applicant | NDM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-12-22 |
Decision Date | 1977-01-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30653405036269 | K761301 | 000 |
30653405006248 | K761301 | 000 |
30653405006187 | K761301 | 000 |
30653405005968 | K761301 | 000 |
20653405034640 | K761301 | 000 |
20653405006616 | K761301 | 000 |
20653405006609 | K761301 | 000 |
30653405006552 | K761301 | 000 |
20653405006432 | K761301 | 000 |
20653405006302 | K761301 | 000 |
20653405006296 | K761301 | 000 |
20653405006272 | K761301 | 000 |
20653405036262 | K761301 | 000 |
20653405006814 | K761301 | 000 |
20653405006807 | K761301 | 000 |
30653405006262 | K761301 | 000 |
30653405006279 | K761301 | 000 |
30653405006293 | K761301 | 000 |
30653405034647 | K761301 | 000 |
30653405034609 | K761301 | 000 |
30653405006811 | K761301 | 000 |
30653405006804 | K761301 | 000 |
30653405006651 | K761301 | 000 |
30653405006613 | K761301 | 000 |
30653405006606 | K761301 | 000 |
30653405006538 | K761301 | 000 |
30653405006521 | K761301 | 000 |
30653405006446 | K761301 | 000 |
30653405006439 | K761301 | 000 |
30653405006385 | K761301 | 000 |
30653405006347 | K761301 | 000 |
30653405006309 | K761301 | 000 |
20653405005961 | K761301 | 000 |