510(k) K162054
K162054 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Medtronic Temporary External Pacemaker 53401". The FDA issued a decision of Substantially Equivalent on October 18, 2016. 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
- October 18, 2016
- Date Received
- July 25, 2016
- Clearance Type
- Traditional
- 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