FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FINN CHAMBERS AQUA
K Number: K123184
·
Decision Dec 19, 2012
Classifications
1
FEI Numbers
364
Registration Numbers
364
Same Product Code
20
Applicant Total
4
Review Days
70
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Basic Information
- Device Name
- FINN CHAMBERS AQUA
- K Number
- K123184
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Smartpractice
- Date Received
- October 10, 2012
- Decision Date
- December 19, 2012
- Product Code
- KXF
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KXF | Applicator, Absorbent Tipped, Non-Sterile | FDA class 1 | General Hospital |
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