510(k) K220470
K220470 is an FDA 510(k) premarket notification submitted by Shanghai Hulu Devices Co., Ltd. for the device "Smart Wireless Stethoscope". The FDA issued a decision of Substantially Equivalent on May 23, 2022. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Shanghai Hulu Devices Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2022
- Date Received
- February 18, 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