The following data is part of a premarket notification filed by Homediagnostic Llc with the FDA for Eclinic Stethopod.
| Device ID | K220099 |
| 510k Number | K220099 |
| Device Name: | EClinic Stethopod |
| Classification | Stethoscope, Electronic |
| Applicant | HomeDiagnostic LLC 3160 De La Cruz Blvd Suite 100 Santa Clara, CA 95054 |
| Contact | Jian Gong |
| 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 | 2022-01-12 |
| Decision Date | 2022-10-20 |