510(k) K021175 ยท CAF Nebulizer (Direct Patient Interface)
AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
| Applicant | Aerogen, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 15, 2002 |
| Received | Apr 12, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021175
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2014 | Aerogen Ltd. The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent Terminated |
CAF | None listed |
| Oct 23, 2014 | Aerogen Ltd. The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent Terminated |
CAF | None listed |
| Oct 23, 2014 | Aerogen Ltd. The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent Terminated |
CAF | None listed |
| Oct 23, 2014 | Aerogen Ltd. The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent Terminated |
CAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.