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FDA 510(k)

CARDIAX

K-Number: K924544 · 1993-07-29

ApplicantFairlake Marketing Group, Inc.
Decision Date1993-07-29
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAX is the device name listed in this FDA 510(k) record. The listed applicant is Fairlake Marketing Group, Inc.. It received FDA 510(k) clearance on 1993-07-29 under 510(k) number K924544. 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 CARDIAX?

CARDIAX is a medical device that received FDA 510(k) clearance on 1993-07-29. The listed applicant is Fairlake Marketing Group, Inc.. The 510(k) number is K924544.

When did CARDIAX receive FDA 510(k) clearance?

CARDIAX received FDA 510(k) clearance on 1993-07-29, under 510(k) number K924544.

Who is the listed applicant for CARDIAX?

The FDA 510(k) record lists Fairlake Marketing Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIAX?

The FDA product code for CARDIAX is DPS.

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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.

K254255S-Patch CardioAIWellysis Corp.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)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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.

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