BIOMONITOR IIIm, BIOMONITOR III
FDA 510(k) clearance K221856 · decided 2022-07-27
Clearance details
- K-number
- K221856
- Device name
- BIOMONITOR IIIm, BIOMONITOR III
- Applicant
- Biotronik, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-27
- Decision date
- 2022-07-27
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- MXD
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lake Oswego, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.