510(k) K081800 ยท DQA Oximeter
T12S TELEMETRY TRANSMITTER
| Applicant | Mortara Instrument, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Sep 24, 2008 |
| Received | Jun 25, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K081800
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient Terminated |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.