510(k) K232261
K232261 is an FDA 510(k) premarket notification submitted by Osypka AG for the device "TME Temporary Myocardial Electrode". The FDA issued a decision of Substantially Equivalent on April 26, 2024. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 2024
- Date Received
- July 31, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Pacemaker, Temporary
- Device Class
- Class II
- Regulation Number
- 870.3680
- Review Panel
- CV
- Submission Type