510(k) K223785
K223785 is an FDA 510(k) premarket notification submitted by Nonagon , Ltd. for the device "N9+". The FDA issued a decision of Substantially Equivalent on April 14, 2023. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2023
- Date Received
- December 16, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Electronic
- Device Class
- Class II
- Regulation Number
- 870.1875
- Review Panel
- CV
- Submission Type