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FDA 510(k)

UNIVISION ECHOCARDIOLOGY SYSTEM

K-Number: K964803 · 1997-02-11

ApplicantNetwork Concepts, Inc.
Decision Date1997-02-11
Product CodeLMB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNIVISION ECHOCARDIOLOGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Network Concepts, Inc.. It received FDA 510(k) clearance on 1997-02-11 under 510(k) number K964803. The device is classified under product code LMB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVISION ECHOCARDIOLOGY SYSTEM?

UNIVISION ECHOCARDIOLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-11. The listed applicant is Network Concepts, Inc.. The 510(k) number is K964803.

When did UNIVISION ECHOCARDIOLOGY SYSTEM receive FDA 510(k) clearance?

UNIVISION ECHOCARDIOLOGY SYSTEM received FDA 510(k) clearance on 1997-02-11, under 510(k) number K964803.

Who is the listed applicant for UNIVISION ECHOCARDIOLOGY SYSTEM?

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

What is the FDA product code for UNIVISION ECHOCARDIOLOGY SYSTEM?

The FDA product code for UNIVISION ECHOCARDIOLOGY SYSTEM is LMB.

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Related Devices (Code: LMB)

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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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