FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHYSIOLOGICAL PRESSURE TRANSDUCER
K Number: K780477
·
Decision Apr 13, 1978
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
1
Review Days
20
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Basic Information
- Device Name
- PHYSIOLOGICAL PRESSURE TRANSDUCER
- K Number
- K780477
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Bell & Howell Instruments
- Date Received
- March 24, 1978
- Decision Date
- April 13, 1978
- 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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