FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
SYNTHEMED PULSE GENERATOR VVI MODEL 1000
K Number: K812464
·
Decision Nov 16, 1981
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
1
Review Days
77
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Basic Information
- Device Name
- SYNTHEMED PULSE GENERATOR VVI MODEL 1000
- K Number
- K812464
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Synthemed Corp.
- Date Received
- August 31, 1981
- Decision Date
- November 16, 1981
- Product Code
- DXY
- 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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | FDA class 3 | Cardiovascular |
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