The following data is part of a premarket notification filed by Shenzhen Narig Bio-medical Technology Co., Ltd. with the FDA for Pulse Oximeter (fro-200, Fro-201, Fro-202, Fro-203, Fro-204, Fro-100, Fro-101, Fro-102, Fro-103, Fro-104).
| Device ID | K211632 |
| 510k Number | K211632 |
| Device Name: | Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) |
| Classification | Oximeter |
| Applicant | Shenzhen Narig Bio-Medical Technology Co., Ltd. 1106 Room, East Tower, Digital Culture Industry Base No.10128 Shennan Road, Nanshan District Shenzhen, CN 518052 |
| Contact | Fei Han |
| Correspondent | Fei Han Shenzhen Narig Bio-Medical Technology Co., Ltd. 1106 Room, East Tower, Digital Culture Industry Base No.10128 Shennan Road, Nanshan District Shenzhen, CN 518052 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-27 |
| Decision Date | 2022-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973927160185 | K211632 | 000 |
| 00850000967410 | K211632 | 000 |
| 00850000967403 | K211632 | 000 |