510(k) K201077
K201077 is an FDA 510(k) premarket notification submitted by Strados Labs for the device "Strados Remote Electronic Stethoscope Platform (RESP)". The FDA issued a decision of Substantially Equivalent on December 20, 2020. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Strados Labs has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2020
- Date Received
- April 22, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Magnetic Tape, Medical
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type