FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
BREEZE NEBULIZER (NBR-10X)
K Number: K133105
·
Decision Jun 24, 2014
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
3
Review Days
267
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Basic Information
- Device Name
- BREEZE NEBULIZER (NBR-10X)
- K Number
- K133105
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Digio2 International Co., Ltd.
- Date Received
- September 30, 2013
- Decision Date
- June 24, 2014
- Product Code
- CAF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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