510(k) K223013
K223013 is an FDA 510(k) premarket notification submitted by Accurkardia, Inc. for the device "AccurECG Analysis System". The FDA issued a decision of Substantially Equivalent on Jun 23, 2023. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Accurkardia, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 23, 2023
- Date Received
- Sep 29, 2022
- 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