K211632 is an FDA 510(k) clearance for the Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Shenzhen Narig Bio-Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 14, 2022, 232 days after receiving the submission on May 27, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K211632 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 2021 |
| Decision Date | January 14, 2022 |
| Days to Decision | 232 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |