510(k) K072235 ยท DQA Oximeter
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Great Neck NY, US |
| Decision | Substantially Equivalent, Oct 19, 2007 |
| Received | Aug 10, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072235
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2010 | Mindray DS USA, Inc., dba Datascope Patient Monitoring SmarTemp Probe Covers for use with the DPM3 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 |
DQA | None listed |
| Apr 15, 2010 | Mindray DS USA, Inc., dba Datascope Patient Monitoring SmarTemp Probe Covers for use with the VS-800 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 Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.