510(k) K873680
K873680 is an FDA 510(k) premarket notification submitted by Oxford Medilog, Inc. for the device "MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on November 23, 1987. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Oxford Medilog, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 1987
- Date Received
- September 14, 1987
- 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