The following data is part of a premarket notification filed by Hefei Mintti Medical Technology Co., Ltd. China with the FDA for Electronic Stethoscope.
| Device ID | K191667 |
| 510k Number | K191667 |
| Device Name: | Electronic Stethoscope |
| Classification | Stethoscope, Electronic |
| Applicant | Hefei Mintti Medical Technology Co., Ltd. China C309, National University Science Park, 602 Huangshan Road, High-tech Zone Hefei, CN 230088 |
| Contact | Shengsheng Cai |
| Correspondent | Shengsheng Cai Hefei Mintti Medical Technology Co., Ltd. China C309, National University Science Park, 602 Huangshan Road, High-tech Zone Hefei, CN 230088 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-21 |
| Decision Date | 2019-12-18 |