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FDA 510(k), K070743, Z6 STIMULATOR
FDA 510(k), K070743, Z6 STIMULATOR
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510(K) Number: K070743
Device Name: Z6 STIMULATOR
Manufacturer: ST CARDIO TECHNOLOGIES, LLC
Device Classification Name: generator, pulse, pacemaker, external programmable (for electrophysiological studies only)
Regulation Number: 870.1750
Classification Product Code: JOQ
Date Received: 03/16/2007
Decision Date: 07/02/2007
Regulation Medical Specialty: Cardiovascular
Device Name: Z6 STIMULATOR
Manufacturer: ST CARDIO TECHNOLOGIES, LLC
Device Classification Name: generator, pulse, pacemaker, external programmable (for electrophysiological studies only)
Regulation Number: 870.1750
Classification Product Code: JOQ
Date Received: 03/16/2007
Decision Date: 07/02/2007
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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