510(k) K211068
K211068 is an FDA 510(k) premarket notification submitted by Entac Medical, Inc. for the device "PrevisEA Device". The FDA issued a decision of Substantially Equivalent on August 4, 2021. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Entac Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2021
- Date Received
- April 12, 2021
- 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