The following data is part of a premarket notification filed by Strados Labs with the FDA for Strados Remote Electronic Stethoscope Platform (resp).
| Device ID | K201077 |
| 510k Number | K201077 |
| Device Name: | Strados Remote Electronic Stethoscope Platform (RESP) |
| Classification | Stethoscope, Electronic |
| Applicant | Strados Labs 1315 Walnut Street, Suite 1101 Philadelphia, PA 19107 |
| Contact | Nicholas Delmonico |
| Correspondent | Grace Powers Powers Regulatory Consulting|64954 2451 Cumberland Parkway SE Suite 3740 Atlanta, GA 30339 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-22 |
| Decision Date | 2020-12-20 |