FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMPLITONE-3
K Number: K812676
·
Decision Oct 13, 1981
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
27
Applicant Total
3
Review Days
21
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Basic Information
- Device Name
- AMPLITONE-3
- K Number
- K812676
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Progressive Technology, Inc.
- Date Received
- September 22, 1981
- Decision Date
- October 13, 1981
- Product Code
- LDE
- 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 |
|---|---|---|---|
| LDE | Stethoscope, Manual | FDA class 1 | Cardiovascular |
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