FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIAC CATHETERIZATION LAB MONITOR SYS
K Number: K770179
·
Decision Apr 5, 1977
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
254
Review Days
68
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Basic Information
- Device Name
- CARDIAC CATHETERIZATION LAB MONITOR SYS
- K Number
- K770179
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- General Electric Co.
- Date Received
- January 27, 1977
- Decision Date
- April 5, 1977
- Product Code
- DXG
- 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 |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | FDA class 2 | Cardiovascular |
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