FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRESSURE MONITOR
K Number: K842194
·
Decision Aug 27, 1984
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
12
Applicant Total
4
Review Days
84
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Basic Information
- Device Name
- PRESSURE MONITOR
- K Number
- K842194
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Norton Texas Medical Products
- Date Received
- June 4, 1984
- Decision Date
- August 27, 1984
- Product Code
- DXS
- 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 |
|---|---|---|---|
| DXS | Gauge, Pressure, Coronary, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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