The following data is part of a premarket notification filed by Csd Labs Gmbh with the FDA for Emurmur Id.
| Device ID | K181988 |
| 510k Number | K181988 |
| Device Name: | EMurmur ID |
| Classification | Stethoscope, Electronic |
| Applicant | CSD Labs GmbH Niklaiplatz 4 Graz, AT 8020 |
| Contact | Andreas Reinisch |
| Correspondent | Yarmela Pavlovic Hogan Lovells US LLP 3 Embarcadero Center San Francisco, CA 94501 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-25 |
| Decision Date | 2019-04-17 |