510(k) K162023
K162023 is an FDA 510(k) premarket notification submitted by Getemed Medizin- Und Informationstechnik AG for the device "CardioDay V2.5". The FDA issued a decision of Substantially Equivalent on March 24, 2017. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Getemed Medizin- Und Informationstechnik AG has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2017
- Date Received
- July 22, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type