SignalHF (IM008)
FDA 510(k) clearance K230842 · decided 2023-10-25
Clearance details
- K-number
- K230842
- Device name
- SignalHF (IM008)
- Applicant
- Implicity, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-03-28
- Decision date
- 2023-10-25
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- QNL
- Device class
- 2
- Regulation number
- 870.2210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.