The following data is part of a premarket notification filed by Shenzhen Jumper Medical Equipment Co., Ltd. with the FDA for Fingertip Pulse Oximeter.
| Device ID | K170965 |
| 510k Number | K170965 |
| Device Name: | Fingertip Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Shenzhen Jumper Medical Equipment Co., Ltd. Jumper Building, No.71-4, Xintian Avenue, Fuyong Street Baoan District, Shenzhen, CN 518103 |
| Contact | Yang Gang |
| Correspondent | Migo Yang Shenzhen Joyantech Consulting Co., Ltd. 1122#,International Mayor Communication Center Baishizhong Road 55# Nanshan District, Shenzhen, CN 518000 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-31 |
| Decision Date | 2017-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818323022091 | K170965 | 000 |
| 06951740540018 | K170965 | 000 |
| 00682891216007 | K170965 | 000 |
| 10854894005415 | K170965 | 000 |
| 04897100310025 | K170965 | 000 |
| 06951740590631 | K170965 | 000 |
| 00867661000356 | K170965 | 000 |
| 10891040000306 | K170965 | 000 |
| 10642632950246 | K170965 | 000 |