510(k) K220196
K220196 is an FDA 510(k) premarket notification submitted by Stratoscientific for the device "Steth IO Spot". The FDA issued a decision of Substantially Equivalent on Mar 24, 2022. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Stratoscientific has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 24, 2022
- Date Received
- Jan 24, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Stethoscope, Electronic
- Device Class
- Class II
- Regulation Number
- 870.1875
- Review Panel
- CV
- Submission Type
- 510(k)