510(k) K201551 ยท JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
KetoSens BT Blood B-Ketone Monitoring System
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Sep 9, 2020 |
| Received | Jun 9, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201551
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.