FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRESSURE MONITORING KIT
K Number: K842352
·
Decision Mar 25, 1985
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
38
Review Days
283
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Basic Information
- Device Name
- PRESSURE MONITORING KIT
- K Number
- K842352
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Utah Medical Products, Inc.
- Date Received
- June 15, 1984
- Decision Date
- March 25, 1985
- Product Code
- DRS
- 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 |
|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | FDA class 2 | Cardiovascular |
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