510(k) K230375
K230375 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "BIOMONITOR IV". The FDA issued a decision of Substantially Equivalent on May 19, 2023. The device falls under product code MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.1025. Biotronik, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2023
- Date Received
- February 13, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type