K160274 is an FDA 510(k) clearance for the Hi bebe plus, a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Bistos Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on September 1, 2016, 212 days after receiving the submission on February 2, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K160274 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 02, 2016 |
| Decision Date | September 01, 2016 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGX — Pump, Breast, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5160 |