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FDA 510(k)

MODEL 100 ACTIVITY MONITOR

K-Number: K011429 · 2001-07-13

ApplicantTelecom Medical, Inc.
Decision Date2001-07-13
Product CodeGYD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL 100 ACTIVITY MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Telecom Medical, Inc.. It received FDA 510(k) clearance on 2001-07-13 under 510(k) number K011429. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 100 ACTIVITY MONITOR?

MODEL 100 ACTIVITY MONITOR is a medical device that received FDA 510(k) clearance on 2001-07-13. The listed applicant is Telecom Medical, Inc.. The 510(k) number is K011429.

When did MODEL 100 ACTIVITY MONITOR receive FDA 510(k) clearance?

MODEL 100 ACTIVITY MONITOR received FDA 510(k) clearance on 2001-07-13, under 510(k) number K011429.

Who is the listed applicant for MODEL 100 ACTIVITY MONITOR?

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

What is the FDA product code for MODEL 100 ACTIVITY MONITOR?

The FDA product code for MODEL 100 ACTIVITY MONITOR is GYD.

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Related Devices (Code: GYD)

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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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