FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISTA VIEWING STATION
K Number: K904975
·
Decision Feb 25, 1991
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
77
Applicant Total
4
Review Days
116
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Basic Information
- Device Name
- VISTA VIEWING STATION
- K Number
- K904975
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Prism Imaging, Inc.
- Date Received
- November 1, 1990
- Decision Date
- February 25, 1991
- Product Code
- DXK
- 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 |
|---|---|---|---|
| DXK | Echocardiograph | FDA class 2 | Cardiovascular |
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