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 |