The following data is part of a premarket notification filed by Bio-detek, Inc. with the FDA for De12 Rapid Trace At-rest Diagnostic Ecg Electrodes.
| Device ID | K853038 |
| 510k Number | K853038 |
| Device Name: | DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | BIO-DETEK, INC. 171 FORBES BLVD. P.O. BOX 809 Mansfield, MA 02048 |
| Contact | Donald C Epstein |
| Correspondent | Donald C Epstein BIO-DETEK, INC. 171 FORBES BLVD. P.O. BOX 809 Mansfield, MA 02048 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-19 |
| Decision Date | 1986-01-07 |