510(k) K821518
K821518 is an FDA 510(k) premarket notification submitted by Alto Development Corp. for the device "MYO/CLIP". The FDA issued a decision of Substantially Equivalent on July 8, 1982. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Alto Development Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 1982
- Date Received
- May 21, 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