The following data is part of a premarket notification filed by Sonavi Labs, Inc. with the FDA for Feelix Stethoscope.
| Device ID | K200862 |
| 510k Number | K200862 |
| Device Name: | Feelix Stethoscope |
| Classification | Stethoscope, Electronic |
| Applicant | Sonavi Labs, Inc. 1100 Wicomico St., Suite 600 Baltimore, MD 21230 |
| Contact | Ian Mclane |
| Correspondent | Ian Mclane Sonavi Labs, Inc. 1100 Wicomico St., Suite 600 Baltimore, MD 21230 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-01 |
| Decision Date | 2020-09-14 |