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 | K140582 |
| 510k Number | K140582 |
| Device Name: | FINGERTIP PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD 4TH FLOOR, JINHUI BUILDING, NANHAI BLVD NANSHAN DISTRICT Shenzhen, Guangdong, CN 518000 |
| Contact | Field Fu |
| Correspondent | Field Fu SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD 4TH FLOOR, JINHUI BUILDING, NANHAI BLVD NANSHAN DISTRICT Shenzhen, Guangdong, CN 518000 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-06 |
| Decision Date | 2014-08-28 |
| Summary: | summary |