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FDA 510(k)

CARDIOSCOPE SONOPLUS 3000

K-Number: K051126 · 2005-05-19

ApplicantPulsonic Ag, Medical Technology
Decision Date2005-05-19
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSCOPE SONOPLUS 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Pulsonic Ag, Medical Technology. It received FDA 510(k) clearance on 2005-05-19 under 510(k) number K051126. 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 CARDIOSCOPE SONOPLUS 3000?

CARDIOSCOPE SONOPLUS 3000 is a medical device that received FDA 510(k) clearance on 2005-05-19. The listed applicant is Pulsonic Ag, Medical Technology. The 510(k) number is K051126.

When did CARDIOSCOPE SONOPLUS 3000 receive FDA 510(k) clearance?

CARDIOSCOPE SONOPLUS 3000 received FDA 510(k) clearance on 2005-05-19, under 510(k) number K051126.

Who is the listed applicant for CARDIOSCOPE SONOPLUS 3000?

The FDA 510(k) record lists Pulsonic Ag, Medical Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOSCOPE SONOPLUS 3000?

The FDA product code for CARDIOSCOPE SONOPLUS 3000 is DPS.

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Related Devices (Code: DPS)

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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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