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FDA 510(k)

MODEL 3200 VASCULAR MINI-LAB

K-Number: K944495 · 1995-06-02

ApplicantParks Medical Electronics, Inc.
Decision Date1995-06-02
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 3200 VASCULAR MINI-LAB is the device name listed in this FDA 510(k) record. The listed applicant is Parks Medical Electronics, Inc.. It received FDA 510(k) clearance on 1995-06-02 under 510(k) number K944495. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 3200 VASCULAR MINI-LAB?

MODEL 3200 VASCULAR MINI-LAB is a medical device that received FDA 510(k) clearance on 1995-06-02. The listed applicant is Parks Medical Electronics, Inc.. The 510(k) number is K944495.

When did MODEL 3200 VASCULAR MINI-LAB receive FDA 510(k) clearance?

MODEL 3200 VASCULAR MINI-LAB received FDA 510(k) clearance on 1995-06-02, under 510(k) number K944495.

Who is the listed applicant for MODEL 3200 VASCULAR MINI-LAB?

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

What is the FDA product code for MODEL 3200 VASCULAR MINI-LAB?

The FDA product code for MODEL 3200 VASCULAR MINI-LAB is MHX.

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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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