FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Stethophone Pro
K Number: K252595
·
Decision Sep 12, 2025
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
4
Review Days
28
Basic Information
- Device Name
- Stethophone Pro
- K Number
- K252595
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sparrow Acoustics, Inc.
- Date Received
- August 15, 2025
- Decision Date
- September 12, 2025
- 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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