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FDA 510(k)

ALEXIS

K-Number: K851261 · 1985-07-01

ApplicantIntex Research & Development Center
Decision Date1985-07-01
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ALEXIS is the device name listed in this FDA 510(k) record. The listed applicant is Intex Research & Development Center. It received FDA 510(k) clearance on 1985-07-01 under 510(k) number K851261. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALEXIS?

ALEXIS is a medical device that received FDA 510(k) clearance on 1985-07-01. The listed applicant is Intex Research & Development Center. The 510(k) number is K851261.

When did ALEXIS receive FDA 510(k) clearance?

ALEXIS received FDA 510(k) clearance on 1985-07-01, under 510(k) number K851261.

Who is the listed applicant for ALEXIS?

The FDA 510(k) record lists Intex Research & Development Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALEXIS?

The FDA product code for ALEXIS is ITI.

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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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