FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NARCO TELECARE TRANSDUCER DOME #700-4000
K Number: K803096
·
Decision Jan 13, 1981
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
30
Review Days
36
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Basic Information
- Device Name
- NARCO TELECARE TRANSDUCER DOME #700-4000
- K Number
- K803096
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Narco Scientific
- Date Received
- December 8, 1980
- Decision Date
- January 13, 1981
- 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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