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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00667673873081 | K140582 | 000 |
| 06951740500258 | K140582 | 000 |
| 06951740500241 | K140582 | 000 |
| 08719699630161 | K140582 | 000 |
| 08719699630017 | K140582 | 000 |
| 08719699630000 | K140582 | 000 |
| 10856471007201 | K140582 | 000 |
| 06951740521383 | K140582 | 000 |
| 00682891216014 | K140582 | 000 |
| 06951740521376 | K140582 | 000 |
| 08719699636361 | K140582 | 000 |
| 08719699636354 | K140582 | 000 |
| 06951740522229 | K140582 | 000 |
| 10860005561725 | K140582 | 000 |
| 08719481721541 | K140582 | 000 |
| 06951740540070 | K140582 | 000 |
| 06951740540063 | K140582 | 000 |
| 06951740540056 | K140582 | 000 |
| 06951740500265 | K140582 | 000 |
| 06951740500203 | K140582 | 000 |
| 06951740500210 | K140582 | 000 |
| 00739810205441 | K140582 | 000 |
| 00739810204253 | K140582 | 000 |
| 00739810204246 | K140582 | 000 |
| 00739810204130 | K140582 | 000 |
| 00739810204123 | K140582 | 000 |
| 00739810204109 | K140582 | 000 |
| 50822383579066 | K140582 | 000 |
| 00817746021233 | K140582 | 000 |
| 00817746020212 | K140582 | 000 |
| 00817746020182 | K140582 | 000 |
| 10863696000337 | K140582 | 000 |
| 00851908007086 | K140582 | 000 |
| 00850253007109 | K140582 | 000 |
| 00845821031310 | K140582 | 000 |
| 06951740538374 | K140582 | 000 |
| 06951740538367 | K140582 | 000 |
| 06951740500227 | K140582 | 000 |
| 06951740540049 | K140582 | 000 |