510(k) K230834
K230834 is an FDA 510(k) premarket notification submitted by Trismed Co., Ltd. for the device "CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H". The FDA issued a decision of Substantially Equivalent on November 21, 2023. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2023
- Date Received
- March 27, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type