FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MyHomeDoc
K Number: K202483
·
Decision Mar 23, 2021
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
147
Applicant Total
1
Review Days
207
Basic Information
- Device Name
- MyHomeDoc
- K Number
- K202483
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MyHomeDoc Ltd.
- Date Received
- August 28, 2020
- Decision Date
- March 23, 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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