The following data is part of a premarket notification filed by National Medical Technology with the FDA for Biodan Type Comet Electrode.
| Device ID | K871668 |
| 510k Number | K871668 |
| Device Name: | BIODAN TYPE COMET ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | NATIONAL MEDICAL TECHNOLOGY 436 RUE ST-HELENE SUITE 102, MONTREAL Quebec, Canada, CA H2y 2k7 |
| Contact | Geoffrey R Eisele |
| Correspondent | Geoffrey R Eisele NATIONAL MEDICAL TECHNOLOGY 436 RUE ST-HELENE SUITE 102, MONTREAL Quebec, Canada, CA H2y 2k7 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-28 |
| Decision Date | 1987-06-10 |