510(k) K220893
K220893 is an FDA 510(k) premarket notification submitted by Strados Labs, Inc. for the device "Strados Remote Electronic Stethoscope Platform (RESP)". The FDA issued a decision of Substantially Equivalent on April 27, 2022. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Strados Labs, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2022
- Date Received
- March 28, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Recorder, Magnetic Tape, Medical
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type