510(k) K193631
K193631 is an FDA 510(k) premarket notification submitted by M3Dicine Pty , Ltd. for the device "Stethee Pro 1, Stethee Pro Software System". The FDA issued a decision of Substantially Equivalent on Oct 9, 2020. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. M3Dicine Pty , Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 9, 2020
- Date Received
- Dec 27, 2019
- 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
- 510(k)