FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Nelson Sentinel Series Basic Chlorine Sentinel
K Number: K193169
·
Decision Oct 29, 2020
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
12
Applicant Total
3
Review Days
349
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Basic Information
- Device Name
- Nelson Sentinel Series Basic Chlorine Sentinel
- K Number
- K193169
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5665
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nelson Environmental Technologies, Inc.
- Date Received
- November 15, 2019
- Decision Date
- October 29, 2020
- Product Code
- MSY
- 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 |
|---|---|---|---|
| MSY | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant | FDA class 2 | Gastroenterology, Urology |
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