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FDA 510(k)

VST3

K-Number: K040942 · 2004-09-15

ApplicantBiowatch Medical, Inc.
Decision Date2004-09-15
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VST3 is the device name listed in this FDA 510(k) record. The listed applicant is Biowatch Medical, Inc.. It received FDA 510(k) clearance on 2004-09-15 under 510(k) number K040942. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VST3?

VST3 is a medical device that received FDA 510(k) clearance on 2004-09-15. The listed applicant is Biowatch Medical, Inc.. The 510(k) number is K040942.

When did VST3 receive FDA 510(k) clearance?

VST3 received FDA 510(k) clearance on 2004-09-15, under 510(k) number K040942.

Who is the listed applicant for VST3?

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

What is the FDA product code for VST3?

The FDA product code for VST3 is DXH. This falls under the Hematology category.

Related Devices (Code: DXH)

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

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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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