The following data is part of a premarket notification filed by Arrhythmia Technologies, Inc. with the FDA for Diagnostic Ep Catheter.
| Device ID | K915563 |
| 510k Number | K915563 |
| Device Name: | DIAGNOSTIC EP CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | ARRHYTHMIA TECHNOLOGIES, INC. 90 WEST PLUMERIA DR. San Jose, CA 95134 |
| Contact | George Savage |
| Correspondent | George Savage ARRHYTHMIA TECHNOLOGIES, INC. 90 WEST PLUMERIA DR. San Jose, CA 95134 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-12 |
| Decision Date | 1992-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994947499 | K915563 | 000 |