FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
AccurSound Electronic Stethoscope (AS101)
K Number: K242971
·
Decision Nov 25, 2024
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
3
Review Days
60
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AccurSound Electronic Stethoscope (AS101)
- K Number
- K242971
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heroic Faith International , Ltd.
- Date Received
- September 26, 2024
- Decision Date
- November 25, 2024
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQD), ordered by most recent decision date.
AiSteth®
FDA 510(k)
FDA Class 2
·Cardiovascular
Tyto Stethoscope (G3)
FDA 510(k)
FDA Class 2
·Cardiovascular
Kneevoice Cartilage Evaluation System (750-3600-001)
FDA 510(k)
FDA Class 2
·Cardiovascular
eMurmur Heart AI
FDA 510(k)
FDA Class 2
·Cardiovascular
Stethophone Pro
FDA 510(k)
FDA Class 2
·Cardiovascular
Eko Foundation Analysis Software with Transformers (EFAST)
FDA 510(k)
FDA Class 2
·Cardiovascular