510(k) K212112
K212112 is an FDA 510(k) premarket notification submitted by Cardiologs Technologies for the device "Cardiologs Holter Platform". The FDA issued a decision of Substantially Equivalent on Nov 18, 2021. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Cardiologs Technologies has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 18, 2021
- Date Received
- Jul 6, 2021
- 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
- 510(k)