FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
K Number: K991775
·
Decision Jun 24, 1999
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
174
Applicant Total
34
Review Days
30
Basic Information
- Device Name
- MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
- K Number
- K991775
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MENNEN MEDICAL, INC.
- Date Received
- May 25, 1999
- Decision Date
- June 24, 1999
- 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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