510(k) K210140
K210140 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "electrocardiograph: SE-1202". The FDA issued a decision of Substantially Equivalent on October 1, 2021. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Edan Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 2021
- Date Received
- January 19, 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