510(k) K080175 ยท BSZ Gas-Machine, Anesthesia
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
| Applicant | Datascope Corp., Patient Monitoring Division, Mahwh NJ, US |
| Decision | Substantially Equivalent, Jun 9, 2008 |
| Received | Jan 24, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K080175
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2010 | Mindray DS USA, Inc., dba Datascope Patient Monitoring Datascope AS3000 Anesthesia System;
Mindray, North America.
The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for au Terminated |
BSZ | None listed |
| Dec 5, 2008 | Mindray DS USA, Inc., dba Datascope Patient Monitoring AS3000 Anesthesia Delivery System. Datascope Patient Monitoring;
A Mindray Global Company.
The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalatio Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.