510(k) K222712
K222712 is an FDA 510(k) premarket notification submitted by Fogg System Company, Inc. for the device "Fogg System Patient Monitoring Cables". The FDA issued a decision of Substantially Equivalent on November 22, 2023. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2023
- Date Received
- September 8, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cable, Transducer And Electrode, Patient, (Including Connector)
- Device Class
- Class II
- Regulation Number
- 870.2900
- Review Panel
- CV
- Submission Type