510(k) K132335 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ULTRASOUND SCANNER FLEX FOCUS 1202
| Applicant | B-K Medical Aps, Herlev, DK |
| Decision | Substantially Equivalent, Jan 10, 2014 |
| Received | Jul 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132335
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2025 | B-K Medical A/S 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed D Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.