510(k) K834583
K834583 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "CLEAR LEADS-RADIOTRANSPARENT WIRES". The FDA issued a decision of Substantially Equivalent on January 30, 1984. The device falls under product code IKD (Cable, Electrode), a Class II device regulated under 21 CFR 890.1175. Quinton, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1984
- Date Received
- December 29, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cable, Electrode
- Device Class
- Class II
- Regulation Number
- 890.1175
- Review Panel
- PM
- Submission Type