FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
AERONEB SOLO; AERONEB SOLO ADAPTER
K Number: K133360
·
Decision Oct 17, 2014
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
5
Review Days
350
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Basic Information
- Device Name
- AERONEB SOLO; AERONEB SOLO ADAPTER
- K Number
- K133360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aerogen, Ltd.
- Date Received
- November 1, 2013
- Decision Date
- October 17, 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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Other Clearances by Aerogen, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251615 | Aerogen Pro-X1 Controller System | Sep 2, 2025 | Substantially Equivalent |
| K232507 | Aerogen®Solo Nebulizer System | May 10, 2024 | Substantially Equivalent |
| K120939 | AERONEB PRO | Apr 26, 2012 | Substantially Equivalent |
| K103635 | CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S | May 13, 2011 | Substantially Equivalent |