510(k) K091068 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
ACCUTORR V MONITOR, MODEL 0998-00-2000
| Applicant | Datascope Corp., Patient Monitoring Division, Mahwh NJ, US |
| Decision | Substantially Equivalent, May 8, 2009 |
| Received | Apr 14, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2010 | Mindray DS USA, Inc., dba Datascope Patient Monitoring SmarTemp Probe Covers with the Accutorr V Monitor; Rx only. Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of 2 Terminated |
DXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.