510(k) K210736
K210736 is an FDA 510(k) premarket notification submitted by Gv Concepts for the device "doctorgram Stethoscope DES-I". The FDA issued a decision of Substantially Equivalent on Jul 27, 2021. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 27, 2021
- Date Received
- Mar 11, 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
- 510(k)