510(k) K071058 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A
| Applicant | Nihon Kohden America, Inc., Foothill CA, US |
| Decision | Substantially Equivalent, Jun 29, 2007 |
| Received | Apr 16, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071058
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2021 | Nihon Kohden America Inc WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI:
ORG 9100A/ 00841983102554
ORG 9110A/ 00841983102561
ORG 9700A/No UDI Open, Classified |
DRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.