The following data is part of a premarket notification filed by Shenzhen Creative Industry Co., Ltd. with the FDA for Handheld Pulse Oximeter, Model Sp-20.
| Device ID | K172792 |
| 510k Number | K172792 |
| Device Name: | Handheld Pulse Oximeter, Model SP-20 |
| Classification | Oximeter |
| Applicant | Shenzhen Creative Industry Co., Ltd. 2/F, Block 3, Nanyou Tian'an Industry Town Shenzhen, CN 518054 |
| Contact | Jia Wang |
| Correspondent | Charlie Mack IRC 2091 Oak Drive Lake Havasu City, AZ 86406 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-15 |
| Decision Date | 2018-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06941900604001 | K172792 | 000 |
| 00817643023965 | K172792 | 000 |
| 00817643023958 | K172792 | 000 |
| 00817643023941 | K172792 | 000 |
| 00817643023927 | K172792 | 000 |