FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
H&S-CONDUCTIVITY STANDARD SOLUTION
K Number: K041636
·
Decision Jul 2, 2004
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
7
Applicant Total
1
Review Days
15
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Basic Information
- Device Name
- H&S-CONDUCTIVITY STANDARD SOLUTION
- K Number
- K041636
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- H & S Technical Services
- Date Received
- June 17, 2004
- Decision Date
- July 2, 2004
- Product Code
- FKH
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FKH | Solution-Test Standard-Conductivity, Dialysis | FDA class 2 | Gastroenterology, Urology |
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