The following data is part of a premarket notification filed by Shenzhen Caremed Medical Technology Co., Ltd. with the FDA for Caremed Patient Cable And Leadwires.
| Device ID | K153188 |
| 510k Number | K153188 |
| Device Name: | Caremed Patient Cable And Leadwires |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| 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 | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-03 |
| Decision Date | 2016-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00663427000116 | K153188 | 000 |
| 06970758500104 | K153188 | 000 |
| 06970758500098 | K153188 | 000 |
| 06970758500012 | K153188 | 000 |
| 06970758507615 | K153188 | 000 |
| 06970758507677 | K153188 | 000 |
| 06970758507646 | K153188 | 000 |
| 06970758507639 | K153188 | 000 |
| 06970758507622 | K153188 | 000 |
| 06970758500111 | K153188 | 000 |
| 06970758500128 | K153188 | 000 |
| 06970758500135 | K153188 | 000 |
| 00663427000109 | K153188 | 000 |
| 00663427000093 | K153188 | 000 |
| 00663427000086 | K153188 | 000 |
| 00663427000079 | K153188 | 000 |
| 00663427000062 | K153188 | 000 |
| 00663427000055 | K153188 | 000 |
| 00663427000048 | K153188 | 000 |
| 06970758500142 | K153188 | 000 |
| 06970758507608 | K153188 | 000 |