510(k) K860767
K860767 is an FDA 510(k) premarket notification submitted by Kone Instruments, Inc. for the device "MODEL E 600 ELECTROCARDIOGRAPH". The FDA issued a decision of Substantially Equivalent on April 23, 1986. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Kone Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1986
- Date Received
- March 3, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector And Alarm, Arrhythmia
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type