510(k) K150246
K150246 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Medtronic Model 5392 External Pulse Generator (EPG)". The FDA issued a decision of Substantially Equivalent on February 18, 2015. The device falls under product code DTE (Pulse-Generator, Pacemaker, External), a Class II device regulated under 21 CFR 870.3600. Medtronic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2015
- Date Received
- February 2, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pulse-Generator, Pacemaker, External
- Device Class
- Class II
- Regulation Number
- 870.3600
- Review Panel
- CV
- Submission Type