The following data is part of a premarket notification filed by Shenzhen Caremed Medical Technology Co., Ltd. with the FDA for Caremed Reusable & Disposable Spo2 Sensors.
| Device ID | K153184 |
| 510k Number | K153184 |
| Device Name: | Caremed Reusable & Disposable SPO2 Sensors |
| Classification | Oximeter |
| Applicant | SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. ZONE B, 3/F, 11 BUILDING, HEBEI INDUSTRIAL AREA, LONGHUA OFFICE, LONGHUA NEW D Shenzhen, CN 518021 |
| Contact | Xinlin Xiao |
| Correspondent | Xinlin Xiao SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. ZONE B, 3/F, 11 BUILDING, HEBEI INDUSTRIAL AREA, LONGHUA OFFICE, LONGHUA NEW D Shenzhen, CN 518021 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-03 |
| Decision Date | 2017-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970758500173 | K153184 | 000 |
| 06970758500166 | K153184 | 000 |
| 06970758500159 | K153184 | 000 |
| 06970758500029 | K153184 | 000 |
| 06970758507691 | K153184 | 000 |
| 06970758507707 | K153184 | 000 |