510(k) K232670
K232670 is an FDA 510(k) premarket notification submitted by MEZOO Co., Ltd. for the device "HiCardi+ H100". The FDA issued a decision of Substantially Equivalent on September 20, 2024. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2024
- Date Received
- September 1, 2023
- 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