FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
K Number: K203223
·
Decision Jan 28, 2021
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
10
Applicant Total
21
Review Days
87
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Basic Information
- Device Name
- Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
- K Number
- K203223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Steris
- Date Received
- November 2, 2020
- Decision Date
- January 28, 2021
- Product Code
- NZA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| NZA | Accessories, Germicide, Cleaning, For Endoscopes | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NZA), ordered by most recent decision date.
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Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
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Reliance Endoscope Processing System
FDA 510(k)
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RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM
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FDA Class 2
·Gastroenterology, Urology
RELIANCE ENDOSCOPE PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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