FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRESSURE TRANSDUCER DOME 1295C
K Number: K841613
·
Decision Oct 24, 1984
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
230
Review Days
184
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Basic Information
- Device Name
- PRESSURE TRANSDUCER DOME 1295C
- K Number
- K841613
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Hewlett-Packard Co.
- Date Received
- April 23, 1984
- Decision Date
- October 24, 1984
- 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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