510(k) K091856
K091856 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES". The FDA issued a decision of Substantially Equivalent on August 7, 2009. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Conmed Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2009
- Date Received
- June 23, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2360
- Review Panel
- CV
- Submission Type