CliniCloud Stethoscope
FDA 510(k) K173448 · Stethocloud Pty.Ltd (Clinicloud)
510(k) numberK173448
Submission
- Device name
- CliniCloud Stethoscope
- Applicant
- Stethocloud Pty.Ltd (Clinicloud)
Melbourne Vic, AU - Received
- November 6, 2017
- Decision date
- January 25, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DQD – Stethoscope, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1875
- Specialty
- Cardiovascular
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| K242971 | AccurSound Electronic Stethoscope (AS101)DQD · Traditional | Heroic Faith International , Ltd. | 11/25/2024SE |
| K240901 | StethophoneDQD · Traditional | Sparrow Acoustics, Inc. | 09/19/2024SE |
More from Sparrow Acoustics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K161325 | CliniCloud Non-contact Thermometer, Model SPL1024FLL · Traditional | 06/22/2016SE |
Questions and answers
When was CliniCloud Stethoscope cleared by the FDA?
CliniCloud Stethoscope (K173448) received a 510(k) decision of Substantially Equivalent on January 25, 2018, 80 days after the submission was received.
What is the product code of K173448?
The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.