510(k) K213279 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
NovaGuide 2 Intelligent Ultrasound
| Applicant | Novasignal Corporation, Los Angeles CA, US |
| Decision | Substantially Equivalent, Mar 2, 2022 |
| Received | Oct 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213279
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2024 | NovaSignal Corp. NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA Open, Classified |
IYN | None listed |
| Jun 27, 2024 | NovaSignal Corp. NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2 Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.