The following data is part of a premarket notification filed by Shenzhen Medke Technology Co., Ltd with the FDA for Medke Oximetry Finger Sensor.
| Device ID | K152390 |
| 510k Number | K152390 |
| Device Name: | Medke Oximetry Finger Sensor |
| Classification | Oximeter |
| Applicant | Shenzhen Medke Technology Co., LTD 4/F,Bldg.A1,Anle Ind. Zone,Hangcheng RD.., Baoan Dist Shenzhen, CN 518126 |
| Contact | Lao Chengxin |
| Correspondent | Lao Chengxin Shenzhen Medke Technology Co., LTD 4/F,Bldg.A1,Anle Ind. Zone,Hangcheng RD.., Baoan Dist Shenzhen, CN 518126 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-24 |
| Decision Date | 2016-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971018115496 | K152390 | 000 |
| 06971018115311 | K152390 | 000 |
| 06971018115304 | K152390 | 000 |
| 06971018115298 | K152390 | 000 |
| 06971018115281 | K152390 | 000 |
| 06971018115274 | K152390 | 000 |
| 06971018115267 | K152390 | 000 |
| 06971018115250 | K152390 | 000 |
| 06971018115243 | K152390 | 000 |
| 06971018115236 | K152390 | 000 |
| 06971018118060 | K152390 | 000 |
| 06971018118046 | K152390 | 000 |
| 06971018117698 | K152390 | 000 |
| 06971018111030 | K152390 | 000 |
| 06971018110613 | K152390 | 000 |
| 00192243000104 | K152390 | 000 |
| 06971018115328 | K152390 | 000 |
| 06971018115335 | K152390 | 000 |
| 06971018115342 | K152390 | 000 |
| 06971018115212 | K152390 | 000 |
| 06971018114949 | K152390 | 000 |
| 06971018115229 | K152390 | 000 |
| 06971018115465 | K152390 | 000 |
| 06971018115458 | K152390 | 000 |
| 06971018115441 | K152390 | 000 |
| 06971018115434 | K152390 | 000 |
| 06971018115427 | K152390 | 000 |
| 06971018115410 | K152390 | 000 |
| 06971018115403 | K152390 | 000 |
| 06971018115397 | K152390 | 000 |
| 06971018115380 | K152390 | 000 |
| 06971018115373 | K152390 | 000 |
| 06971018115366 | K152390 | 000 |
| 06971018115359 | K152390 | 000 |
| 00192243000098 | K152390 | 000 |