510(k) K183192 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
CapsoCam Plus (SV-3)
| Applicant | CapsoVision, Inc., Saratoga CA, US |
| Decision | Substantially Equivalent, Apr 19, 2019 |
| Received | Nov 19, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183192
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2019 | Capso Vision, Inc. CapsoCAM Plus, UDI: 00867770000209 Terminated |
NEZ | None listed |
| Jul 3, 2019 | Capso Vision, Inc. CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of Terminated |
NEZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.