The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Protab Ecg Tabb Electrode.
| Device ID | K040784 |
| 510k Number | K040784 |
| Device Name: | PROTAB ECG TABB ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | BIO PROTECH, INC. 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | N.e. Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-03-29 |
| Decision Date | 2004-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20304040007482 | K040784 | 000 |
| 50885380048423 | K040784 | 000 |
| 50885380048430 | K040784 | 000 |
| 20817120020559 | K040784 | 000 |
| 20817120020580 | K040784 | 000 |
| 20817120020597 | K040784 | 000 |
| 20817325021559 | K040784 | 000 |
| 20817325021566 | K040784 | 000 |
| 20817325021573 | K040784 | 000 |
| 20817325021580 | K040784 | 000 |
| 20817325021597 | K040784 | 000 |
| 28809083947754 | K040784 | 000 |