The following data is part of a premarket notification filed by M3dicine Pty. Ltd. with the FDA for Stethee Pro.
| Device ID | K172296 |
| 510k Number | K172296 |
| Device Name: | Stethee Pro |
| Classification | Stethoscope, Electronic |
| Applicant | M3dicine Pty. Ltd. 1389 Beenleigh Road Brisbane, AU 4112 |
| Contact | Nayyar Hussain |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-07-31 |
| Decision Date | 2017-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09351356000017 | K172296 | 000 |