FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVOTECH ECR
K Number: K140977
·
Decision Dec 22, 2014
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
56
Applicant Total
54
Review Days
250
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Basic Information
- Device Name
- EVOTECH ECR
- K Number
- K140977
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Sterilization Products
- Date Received
- April 16, 2014
- Decision Date
- December 22, 2014
- Product Code
- FEB
- 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 |
|---|---|---|---|
| FEB | Accessories, Cleaning, For Endoscope | FDA class 2 | Gastroenterology, Urology |
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| K160818 | STERRAD® NX Sterilizer with ALLClear Technology | Sep 27, 2016 | Substantially Equivalent |
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| K151971 | STERRAD CYCLESURE 24 Biological Indicator | Oct 29, 2015 | Substantially Equivalent |
| K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | Apr 3, 2015 | Substantially Equivalent |
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