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FDA 510(k)

TELEMEDCARE HEALTH MONITOR

K-Number: K103796 · 2011-08-03

ApplicantTelemedcare Pty, Ltd.
Decision Date2011-08-03
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TELEMEDCARE HEALTH MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Telemedcare Pty, Ltd.. It received FDA 510(k) clearance on 2011-08-03 under 510(k) number K103796. 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 TELEMEDCARE HEALTH MONITOR?

TELEMEDCARE HEALTH MONITOR is a medical device that received FDA 510(k) clearance on 2011-08-03. The listed applicant is Telemedcare Pty, Ltd.. The 510(k) number is K103796.

When did TELEMEDCARE HEALTH MONITOR receive FDA 510(k) clearance?

TELEMEDCARE HEALTH MONITOR received FDA 510(k) clearance on 2011-08-03, under 510(k) number K103796.

Who is the listed applicant for TELEMEDCARE HEALTH MONITOR?

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

What is the FDA product code for TELEMEDCARE HEALTH MONITOR?

The FDA product code for TELEMEDCARE HEALTH MONITOR 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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