K201077 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 (Philadelphia, US). The FDA issued a Cleared decision on December 20, 2020, 242 days after receiving the submission on April 22, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K201077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2020 |
| Decision Date | December 20, 2020 |
| Days to Decision | 242 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 |