510(k) K182790
K182790 is an FDA 510(k) premarket notification submitted by Cardio-Phoenix, Inc. for the device "Cardio-TriTest v6.5". The FDA issued a decision of Substantially Equivalent on Dec 14, 2018. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Cardio-Phoenix, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 14, 2018
- Date Received
- Oct 1, 2018
- Clearance Type
- Special
- 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
- 510(k)