FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ERIKA CAPD PREP KIT #30-9501-5
K Number: K820179
·
Decision Feb 19, 1982
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
82
Applicant Total
43
Review Days
28
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Basic Information
- Device Name
- ERIKA CAPD PREP KIT #30-9501-5
- K Number
- K820179
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Erika, Inc.
- Date Received
- January 22, 1982
- Decision Date
- February 19, 1982
- Product Code
- FKX
- 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 |
|---|---|---|---|
| FKX | System, Peritoneal, Automatic Delivery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)
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Other Clearances by Erika, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853134 | NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 | Nov 6, 1985 | Substantially Equivalent |
| K852310 | NATURALYTE BICARBONATE CONCENTRATE-DRY PACK | Jul 26, 1985 | Substantially Equivalent |
| K852309 | ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 | Jul 26, 1985 | Substantially Equivalent |
| K850865 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- | Apr 3, 1985 | Substantially Equivalent |
| K850866 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L | Apr 3, 1985 | Substantially Equivalent |
| K850655 | TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 | Mar 7, 1985 | Substantially Equivalent |
| K850654 | TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID | Mar 7, 1985 | Substantially Equivalent |
| K842436 | ERIKA NEGATIVE PRESS. ARTERIAL BLOOD | Jul 13, 1984 | Substantially Equivalent |
| K831175 | FILTRYZER HOLLOW FIBER ARTIF. KIDNEY | Jun 22, 1984 | Substantially Equivalent |
| K831173 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER | Jun 22, 1984 | Substantially Equivalent |