510(k) K211632 ยท DQA Oximeter
Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
| Applicant | Shenzhen Narig Bio-Medical Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jan 14, 2022 |
| Received | May 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211632
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.