FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
V. MUELLER CAMERA CONTROLLER WITH STORAGE CART
K Number: K093616
·
Decision Dec 23, 2009
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
9
Applicant Total
2
Review Days
34
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Basic Information
- Device Name
- V. MUELLER CAMERA CONTROLLER WITH STORAGE CART
- K Number
- K093616
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carefusion 2200
- Date Received
- November 19, 2009
- Decision Date
- December 23, 2009
- Product Code
- OCV
- 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 |
|---|---|---|---|
| OCV | Endoscope Holder | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Carefusion 2200
| K Number | Device Name | ||
|---|---|---|---|
| K102179 | ENVIEW (TM) | Dec 2, 2010 | Substantially Equivalent |