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FDA 510(k)

ALCATEL-LUCENT TELEHEATH MANAGER

K-Number: K092635 · 2009-09-10

ApplicantAlcatel-Lucent Canada, Inc.
Decision Date2009-09-10
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALCATEL-LUCENT TELEHEATH MANAGER is the device name listed in this FDA 510(k) record. The listed applicant is Alcatel-Lucent Canada, Inc.. It received FDA 510(k) clearance on 2009-09-10 under 510(k) number K092635. 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 ALCATEL-LUCENT TELEHEATH MANAGER?

ALCATEL-LUCENT TELEHEATH MANAGER is a medical device that received FDA 510(k) clearance on 2009-09-10. The listed applicant is Alcatel-Lucent Canada, Inc.. The 510(k) number is K092635.

When did ALCATEL-LUCENT TELEHEATH MANAGER receive FDA 510(k) clearance?

ALCATEL-LUCENT TELEHEATH MANAGER received FDA 510(k) clearance on 2009-09-10, under 510(k) number K092635.

Who is the listed applicant for ALCATEL-LUCENT TELEHEATH MANAGER?

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

What is the FDA product code for ALCATEL-LUCENT TELEHEATH MANAGER?

The FDA product code for ALCATEL-LUCENT TELEHEATH MANAGER is DRG.

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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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