510(k) K181912
K181912 is an FDA 510(k) premarket notification submitted by Medical Graphics Corporation for the device "Ascent Cardiorespiratory Diagnostic Software". The FDA issued a decision of Substantially Equivalent on April 12, 2019. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890. Medical Graphics Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2019
- Date Received
- July 17, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Calculator, Predicted Values, Pulmonary Function
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- AN
- Submission Type