510(k) K223382
K223382 is an FDA 510(k) premarket notification submitted by Aevice Health Pte. , Ltd. for the device "AeviceMD". The FDA issued a decision of Substantially Equivalent on July 7, 2023. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Aevice Health Pte. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 2023
- Date Received
- November 7, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Magnetic Tape, Medical
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type