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FDA 510(k)

CARDIOSOFT PC ECG, USB VERSION

K-Number: K052295 · 2006-01-13

ApplicantCardiosoft, L.P.
Decision Date2006-01-13
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSOFT PC ECG, USB VERSION is the device name listed in this FDA 510(k) record. The listed applicant is Cardiosoft, L.P.. It received FDA 510(k) clearance on 2006-01-13 under 510(k) number K052295. 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 CARDIOSOFT PC ECG, USB VERSION?

CARDIOSOFT PC ECG, USB VERSION is a medical device that received FDA 510(k) clearance on 2006-01-13. The listed applicant is Cardiosoft, L.P.. The 510(k) number is K052295.

When did CARDIOSOFT PC ECG, USB VERSION receive FDA 510(k) clearance?

CARDIOSOFT PC ECG, USB VERSION received FDA 510(k) clearance on 2006-01-13, under 510(k) number K052295.

Who is the listed applicant for CARDIOSOFT PC ECG, USB VERSION?

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

What is the FDA product code for CARDIOSOFT PC ECG, USB VERSION?

The FDA product code for CARDIOSOFT PC ECG, USB VERSION 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.

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Official Source

View on FDA Database →

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

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