510(k) K896632
K896632 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC MODEL 5401B TEST CABLE". The FDA issued a decision of Substantially Equivalent on December 13, 1989. The device falls under product code DTC (Analyzer, Pacemaker Generator Function), a Class II device regulated under 21 CFR 870.3630. Medtronic Vascular has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 1989
- Date Received
- November 22, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Pacemaker Generator Function
- Device Class
- Class II
- Regulation Number
- 870.3630
- Review Panel
- CV
- Submission Type