510(k) K200444
K200444 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "Biomonitor III, Biomonitor IIIm". The FDA issued a decision of Substantially Equivalent on April 23, 2020. 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
- April 23, 2020
- Date Received
- February 24, 2020
- 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