510(k) K812517
K812517 is an FDA 510(k) premarket notification submitted by Medics Instrument Corp. for the device "CARDIAC PACING ELECTRODES". The FDA issued a decision of Substantially Equivalent on October 13, 1981. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Medics Instrument Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1981
- Date Received
- September 2, 1981
- 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