FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003
K Number: K093718
·
Decision Feb 22, 2010
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
2
Applicant Total
1
Review Days
82
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Basic Information
- Device Name
- ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003
- K Number
- K093718
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zutron Medical, LLC
- Date Received
- December 2, 2009
- Decision Date
- February 22, 2010
- Product Code
- FCY
- 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 |
|---|---|---|---|
| FCY | Bulb, Inflation, For Endoscope | FDA class 1 | Gastroenterology, Urology |
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