FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MODIFICATION TO: HORIZON 9000WS
K Number: K032997
·
Decision Oct 15, 2003
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
21
Review Days
20
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Basic Information
- Device Name
- MODIFICATION TO: HORIZON 9000WS
- K Number
- K032997
- 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 , Ltd.
- Date Received
- September 25, 2003
- Decision Date
- October 15, 2003
- 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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