FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANDUCER PROTECTOR
K Number: K851428
·
Decision May 21, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
34
Applicant Total
1
Review Days
41
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Basic Information
- Device Name
- TRANDUCER PROTECTOR
- K Number
- K851428
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Galvin Industries, Inc.
- Date Received
- April 10, 1985
- Decision Date
- May 21, 1985
- 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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