The following data is part of a premarket notification filed by Strados Labs, Inc. with the FDA for Strados Remote Electronic Stethoscope Platform (resp).
| Device ID | K220893 |
| 510k Number | K220893 |
| Device Name: | Strados Remote Electronic Stethoscope Platform (RESP) |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | Strados Labs, Inc. 1315 Walnut Street, Suite 1101 Philadelphia, PA 19107 |
| Contact | Nicholas Delmonico |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-03-28 |
| Decision Date | 2022-04-27 |