FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMODIALYSIS TRANSDUCER PROTECTOR
K Number: K812162
·
Decision Sep 24, 1981
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
34
Applicant Total
1
Review Days
57
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Basic Information
- Device Name
- HEMODIALYSIS TRANSDUCER PROTECTOR
- K Number
- K812162
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Membrana
- Date Received
- July 29, 1981
- Decision Date
- September 24, 1981
- Product Code
- FIB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FIB | Protector, Transducer, Dialysis | FDA class 2 | Gastroenterology, Urology |
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