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FDA 510(k)

TELEPAX

K-Number: K011173 · 2001-07-11

ApplicantImed Systems & Consulting, LLC
Decision Date2001-07-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TELEPAX is the device name listed in this FDA 510(k) record. The listed applicant is Imed Systems & Consulting, LLC. It received FDA 510(k) clearance on 2001-07-11 under 510(k) number K011173. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELEPAX?

TELEPAX is a medical device that received FDA 510(k) clearance on 2001-07-11. The listed applicant is Imed Systems & Consulting, LLC. The 510(k) number is K011173.

When did TELEPAX receive FDA 510(k) clearance?

TELEPAX received FDA 510(k) clearance on 2001-07-11, under 510(k) number K011173.

Who is the listed applicant for TELEPAX?

The FDA 510(k) record lists Imed Systems & Consulting, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TELEPAX?

The FDA product code for TELEPAX is LLZ.

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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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