The following data is part of a premarket notification filed by Foshan Care Medical Technology Co., Ltd. with the FDA for Care Su01a Suction Aspirator.
| Device ID | K130001 |
| 510k Number | K130001 |
| Device Name: | CARE SU01A SUCTION ASPIRATOR |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. THE 2F AND 3F, G BUILDING, NO.1 HUABAO ROAD SOUTHERN Foshan, Guangdong, CN 528000 |
| Contact | Gang Wu |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-01-02 |
| Decision Date | 2013-07-25 |
| Summary: | summary |