The following data is part of a premarket notification filed by M3dicine Pty Ltd. with the FDA for Stethee Pro 1, Stethee Pro Software System.
| Device ID | K193631 |
| 510k Number | K193631 |
| Device Name: | Stethee Pro 1, Stethee Pro Software System |
| Classification | Stethoscope, Electronic |
| Applicant | M3DICINE Pty Ltd. Level 1, 88 Brandl Street Eight Mile Plains, AU 4113 |
| Contact | Nayyar Hussain |
| Correspondent | Ginger Cantor Centaur Consulting LLC W9281 710th Avenue River Falls, WI 54022 |
| Product Code | DQD |
| Subsequent Product Code | DQC |
| Subsequent Product Code | DRG |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-27 |
| Decision Date | 2020-10-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09351356000055 | K193631 | 000 |
| 09351356000048 | K193631 | 000 |
| 09351356000031 | K193631 | 000 |