K220893 is an FDA 510(k) clearance for the Strados Remote Electronic Stethoscope Platform (RESP). This device is classified as a Recorder, Magnetic Tape, Medical (Class II - Special Controls, product code DSH).
Submitted by Strados Labs, Inc. (Philadelphia, US). The FDA issued a Cleared decision on April 27, 2022, 30 days after receiving the submission on March 28, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K220893 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2022 |
| Decision Date | April 27, 2022 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DSH - Recorder, Magnetic Tape, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |