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FDA 510(k)

CARDIOQ, MODEL 9051-7005

K-Number: K031706 · 2003-08-06

ApplicantDeltex Medical
Decision Date2003-08-06
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOQ, MODEL 9051-7005 is the device name listed in this FDA 510(k) record. The listed applicant is Deltex Medical. It received FDA 510(k) clearance on 2003-08-06 under 510(k) number K031706. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOQ, MODEL 9051-7005?

CARDIOQ, MODEL 9051-7005 is a medical device that received FDA 510(k) clearance on 2003-08-06. The listed applicant is Deltex Medical. The 510(k) number is K031706.

When did CARDIOQ, MODEL 9051-7005 receive FDA 510(k) clearance?

CARDIOQ, MODEL 9051-7005 received FDA 510(k) clearance on 2003-08-06, under 510(k) number K031706.

Who is the listed applicant for CARDIOQ, MODEL 9051-7005?

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

What is the FDA product code for CARDIOQ, MODEL 9051-7005?

The FDA product code for CARDIOQ, MODEL 9051-7005 is DPW.

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Other records listing Deltex Medical as applicant

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.

K052989DP240 240 HOUR DOPPLER PROBEK951369EDM

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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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