FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
K Number: K060321
·
Decision May 15, 2006
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
147
Applicant Total
39
Review Days
95
Basic Information
- Device Name
- ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
- K Number
- K060321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AMERICAN DIAGNOSTIC CORP.
- Date Received
- February 9, 2006
- Decision Date
- May 15, 2006
- Product Code
- DQD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CH
- 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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