510(k) K160016
K160016 is an FDA 510(k) premarket notification submitted by Stratoscientific, Inc. for the device "Steth IO". The FDA issued a decision of Substantially Equivalent on Jul 15, 2016. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Stratoscientific, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 15, 2016
- Date Received
- Jan 5, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Electronic
- Device Class
- Class II
- Regulation Number
- 870.1875
- Review Panel
- CV
- Submission Type
- 510(k)