SignalHF (IM008)— 510(k) K230842

Substantially Equivalent

Implicity, Inc.

FDA 510(k) clearance K230842 for SignalHF (IM008), Substantially Equivalent on 2023-10-25. Applicant: Implicity, Inc.. Device class: 2.

Clearance details

Applicant
Implicity, Inc.
Product code
Code QNL
Device class
Class 2
Regulation
21 CFR 870.2210
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cambridge, MA, US
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