FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER
K Number: K850898
·
Decision Jul 25, 1985
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
1
Review Days
143
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Basic Information
- Device Name
- MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER
- K Number
- K850898
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medi-Trace Products Division
- Date Received
- March 4, 1985
- Decision Date
- July 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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