510(k) K173448
K173448 is an FDA 510(k) premarket notification submitted by Stethocloud Pty.Ltd (Clinicloud) for the device "CliniCloud Stethoscope". The FDA issued a decision of Substantially Equivalent on Jan 25, 2018. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Stethocloud Pty.Ltd (Clinicloud) has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 25, 2018
- Date Received
- Nov 6, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Stethoscope, Electronic
- Device Class
- Class II
- Regulation Number
- 870.1875
- Review Panel
- CV
- Submission Type
- 510(k)