SignalHF

GUDID 03770025266015

Implicity Inc.

Cardiology information system application software
Primary Device ID03770025266015
NIH Device Record Keye0425f32-e74a-420b-9f09-bae9699daf19
Commercial Distribution StatusIn Commercial Distribution
Brand NameSignalHF
Version Model NumberV1.0.2
Company DUNS118346169
Company NameImplicity Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103770025266015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-24
Device Publish Date2024-04-16

Devices Manufactured by Implicity Inc.

03770025266015 - SignalHF2024-04-24
03770025266015 - SignalHF2024-04-24
03770025266008 - ILR ECG Analyzer2024-04-23

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