510(k) K821333
K821333 is an FDA 510(k) premarket notification submitted by Medics Instrument Corp. for the device "ATRIAL J TEMPORARY PACING ELECTRODESS". The FDA issued a decision of Substantially Equivalent on June 2, 1982. 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
- June 2, 1982
- Date Received
- May 5, 1982
- 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