510(k) K181966 ยท OWB Interventional Fluoroscopic X-Ray System
SmartPerfusion
| Applicant | Philips Medical Systems Nederlands B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Aug 17, 2018 |
| Received | Jul 23, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181966
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.