K130001 is an FDA 510(k) clearance for the CARE SU01A SUCTION ASPIRATOR. This device is classified as a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II - Special Controls, product code JCX).
Submitted by Foshan Care Medical Technology Co., Ltd. (Foshan, Guangdong, CN). The FDA issued a Cleared decision on July 25, 2013, 204 days after receiving the submission on January 2, 2013.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K130001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2013 |
| Decision Date | July 25, 2013 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | JCX - Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |