The following data is part of a premarket notification filed by Frantz Medical Development, Ltd. with the FDA for Frantz Medical Electrode.
| Device ID | K863508 |
| 510k Number | K863508 |
| Device Name: | FRANTZ MEDICAL ELECTRODE |
| Classification | Ballistocardiograph |
| Applicant | FRANTZ MEDICAL DEVELOPMENT, LTD. 595 MADISON AVE. New York, NY 10022 |
| Contact | Mark G Frantz |
| Correspondent | Mark G Frantz FRANTZ MEDICAL DEVELOPMENT, LTD. 595 MADISON AVE. New York, NY 10022 |
| Product Code | DXR |
| CFR Regulation Number | 870.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1987-02-06 |