510(k) K954028 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
HP SONOS ULTRASOUND IMAGING SYSTEM
| Applicant | Hewlett-Packard Co., Andover MA, US |
| Decision | Substantially Equivalent, Aug 8, 1996 |
| Received | Aug 28, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954028
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2025 | Philips Ultrasound, Inc OMNI II TEE Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc OMNI III TEE Transducer Probe Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.