Data / Medical devices / France / Implicity
Implicity: FDA-registered device maker in Paris 1er Arrondissement, France, 2 510(k) clearances
Implicity is registered with the FDA (registration 3030125003) in Paris 1er Arrondissement, France. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 25, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3030125003
- Address
- 2 Rue Du Colonel Driant, Paris 1er Arrondissement, France, 75001
- Owner or operator
- Implicity (10089468)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 11, 2023
- Registered through
- 2027
- Brand names listed
- IM007 (ILR ECG Analyzer), SignalHF
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adjunctive Predictive Cardiovascular Indicator | QAQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Medium-Term Adjunctive Predictive Cardiovascular Indicator | QNL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 25, 2023 | K230842 | SignalHF (IM008) | QNL | Substantially Equivalent | Implicity, Inc. | accessdata.fda.gov |
| November 3, 2021 | K210543 | IM007 | DQK | Substantially Equivalent | Implicity, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Medium-Term Adjunctive Predictive Cardiovascular Indicator
- All makers of Adjunctive Predictive Cardiovascular Indicator
- All makers of Computer, Diagnostic, Programmable
- All makers of Electrocardiograph
Updated October 25, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.