The following data is part of a premarket notification filed by Cardiotronics Systems, Inc. with the FDA for 700-fr Series Radiolucent Stimulation Electrodes.
| Device ID | K964991 |
| 510k Number | K964991 |
| Device Name: | 700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIOTRONICS SYSTEMS, INC. 5966 LA PLACE CT. Carlsbad, CA 92008 |
| Contact | Tim J Way |
| Correspondent | Tim J Way CARDIOTRONICS SYSTEMS, INC. 5966 LA PLACE CT. Carlsbad, CA 92008 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-13 |
| Decision Date | 1997-01-15 |