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FDA 510(k)

QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)

K-Number: K093172 · 2010-01-20

ApplicantDynacardia, Inc.
Decision Date2010-01-20
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) is the device name listed in this FDA 510(k) record. The listed applicant is Dynacardia, Inc.. It received FDA 510(k) clearance on 2010-01-20 under 510(k) number K093172. 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 QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)?

QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) is a medical device that received FDA 510(k) clearance on 2010-01-20. The listed applicant is Dynacardia, Inc.. The 510(k) number is K093172.

When did QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) receive FDA 510(k) clearance?

QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) received FDA 510(k) clearance on 2010-01-20, under 510(k) number K093172.

Who is the listed applicant for QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)?

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

What is the FDA product code for QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)?

The FDA product code for QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) 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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