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FDA 510(k)

QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER

K-Number: K050088 · 2005-02-08

Decision Date2005-02-08
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Neoprobe Corp.. It received FDA 510(k) clearance on 2005-02-08 under 510(k) number K050088. 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 QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER?

QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER is a medical device that received FDA 510(k) clearance on 2005-02-08. The listed applicant is Neoprobe Corp.. The 510(k) number is K050088.

When did QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER receive FDA 510(k) clearance?

QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER received FDA 510(k) clearance on 2005-02-08, under 510(k) number K050088.

Who is the listed applicant for QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER?

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

What is the FDA product code for QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER?

The FDA product code for QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER is DPW.

Related Clinical Trials

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.

Other records listing Neoprobe Corp. 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.

Related Devices (Code: DPW)

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.

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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