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FDA 510(k)

CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION

K-Number: K031638 · 2003-07-21

ApplicantElectromed Imaging, Inc.
Decision Date2003-07-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Electromed Imaging, Inc.. It received FDA 510(k) clearance on 2003-07-21 under 510(k) number K031638. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION?

CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION is a medical device that received FDA 510(k) clearance on 2003-07-21. The listed applicant is Electromed Imaging, Inc.. The 510(k) number is K031638.

When did CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION receive FDA 510(k) clearance?

CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION received FDA 510(k) clearance on 2003-07-21, under 510(k) number K031638.

Who is the listed applicant for CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION?

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

What is the FDA product code for CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION?

The FDA product code for CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION is LLZ.

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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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