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FDA 510(k)

TELENABLE EMS SYSTEM

K-Number: K040663 · 2004-06-30

ApplicantMolex, Inc.
Decision Date2004-06-30
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TELENABLE EMS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Molex, Inc.. It received FDA 510(k) clearance on 2004-06-30 under 510(k) number K040663. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELENABLE EMS SYSTEM?

TELENABLE EMS SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-30. The listed applicant is Molex, Inc.. The 510(k) number is K040663.

When did TELENABLE EMS SYSTEM receive FDA 510(k) clearance?

TELENABLE EMS SYSTEM received FDA 510(k) clearance on 2004-06-30, under 510(k) number K040663.

Who is the listed applicant for TELENABLE EMS SYSTEM?

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

What is the FDA product code for TELENABLE EMS SYSTEM?

The FDA product code for TELENABLE EMS SYSTEM is DRG.

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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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