FDA 510(k)

KardioScreen

K-Number: K191692 · 2020-01-10

ApplicantImedrix Inc. (Formerly Piitech Inc.)

Decision Date2020-01-10

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

KardioScreen is the device name listed in this FDA 510(k) record. The listed applicant is Imedrix Inc. (Formerly Piitech Inc.). It received FDA 510(k) clearance on 2020-01-10 under 510(k) number K191692. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KardioScreen?

KardioScreen is a medical device that received FDA 510(k) clearance on 2020-01-10. The listed applicant is Imedrix Inc. (Formerly Piitech Inc.). The 510(k) number is K191692.

When did KardioScreen receive FDA 510(k) clearance?

KardioScreen received FDA 510(k) clearance on 2020-01-10, under 510(k) number K191692.

Who is the listed applicant for KardioScreen?

The FDA 510(k) record lists Imedrix Inc. (Formerly Piitech Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KardioScreen?

The FDA product code for KardioScreen is DPS.

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs Holter PlatformPhilips France Commercial K243252ZBPro DiagnosticZbeats, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.