FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
eKuore Pro 4T - REF EP0098
K Number: K212013
·
Decision Nov 10, 2021
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
5
Review Days
135
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Basic Information
- Device Name
- eKuore Pro 4T - REF EP0098
- K Number
- K212013
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chip Ideas Electronics S.L.
- Date Received
- June 28, 2021
- Decision Date
- November 10, 2021
- Product Code
- DQD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQD | Stethoscope, Electronic | FDA class 2 | Cardiovascular |
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Other Clearances by Chip Ideas Electronics S.L.
| K Number | Device Name | ||
|---|---|---|---|
| K211779 | ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. | May 26, 2022 | Substantially Equivalent |
| K201742 | eKuore One Wireless Electronic Interface for stethoscope | Nov 24, 2020 | Substantially Equivalent |
| K203007 | eKuore Pro Series | Oct 30, 2020 | Substantially Equivalent |
| K181882 | eKuore One electronic interface for stethoscope | Mar 27, 2019 | Substantially Equivalent |