The following data is part of a premarket notification filed by Imediplus, Inc. with the FDA for Cardiart Electronic Stethoscope Model Ds101 Omni-steth Electronic Stethoscope Model Omni-steth.
| Device ID | K182196 |
| 510k Number | K182196 |
| Device Name: | Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth |
| Classification | Stethoscope, Electronic |
| Applicant | Imediplus, Inc. 2F, 12, ShengYi Rd. Sec.2 Chupei City, TW 30261 |
| Contact | Moriah Hsieh |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-08-14 |
| Decision Date | 2018-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719874400026 | K182196 | 000 |
| 04719874400019 | K182196 | 000 |