FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S
K Number: K103635
·
Decision May 13, 2011
Classifications
1
FEI Numbers
187
Registration Numbers
188
Same Product Code
503
Applicant Total
3
Review Days
151
Basic Information
- Device Name
- CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S
- K Number
- K103635
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- AEROGEN LTD
- Date Received
- December 13, 2010
- Decision Date
- May 13, 2011
- 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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