FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIEMENS MODEL 146-146A EXTERNAL PULSE G
K Number: K810566
·
Decision Apr 1, 1981
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
5
Review Days
29
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Basic Information
- Device Name
- SIEMENS MODEL 146-146A EXTERNAL PULSE G
- K Number
- K810566
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cynergy
- Date Received
- March 3, 1981
- Decision Date
- April 1, 1981
- Product Code
- DTE
- 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 |
|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | FDA class 2 | Cardiovascular |
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