The following data is part of a premarket notification filed by St Cardio Technologies, Llc with the FDA for Z6 Stimulator.
| Device ID | K070743 |
| 510k Number | K070743 |
| Device Name: | Z6 STIMULATOR |
| Classification | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | ST CARDIO TECHNOLOGIES, LLC 3901 TROON CIRCLE Broomfield, CO 80020 |
| Contact | Bill Abboud |
| Correspondent | Bill Abboud ST CARDIO TECHNOLOGIES, LLC 3901 TROON CIRCLE Broomfield, CO 80020 |
| Product Code | JOQ |
| CFR Regulation Number | 870.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-16 |
| Decision Date | 2007-07-02 |
| Summary: | summary |