FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE VITA 2 DISPOSABLE DIALYZER
K Number: K801634
·
Decision Dec 17, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
11
Applicant Total
3
Review Days
155
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Basic Information
- Device Name
- THE VITA 2 DISPOSABLE DIALYZER
- K Number
- K801634
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Bellco Artifidial Organ Spec., Inc.
- Date Received
- July 15, 1980
- Decision Date
- December 17, 1980
- Product Code
- FHS
- 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 |
|---|---|---|---|
| FHS | Dialyzer, Single Coil | FDA class 2 | Gastroenterology, Urology |
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