510(k) K183425
K183425 is an FDA 510(k) premarket notification submitted by Schiller AG for the device "CARDIOVIT AT-102 G2". The FDA issued a decision of Substantially Equivalent on March 2, 2020. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Schiller AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 2020
- Date Received
- December 11, 2018
- 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