The following data is part of a premarket notification filed by Imediplus Inc. with the FDA for Electronic Stethoscope Ds301.
| Device ID | K160023 |
| 510k Number | K160023 |
| Device Name: | Electronic Stethoscope DS301 |
| Classification | Stethoscope, Electronic |
| Applicant | IMEDIPLUS INC. 2F, 12, SHENGYI RD.SEC.2 Chubei City, TW 30261 |
| Contact | Shirley Lai |
| Correspondent | Shirley Lai IMEDIPLUS INC. 2F, 12, SHENGYI RD.SEC.2 Chubei City, TW 30261 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-06 |
| Decision Date | 2016-09-30 |
| Summary: | summary |