FDA 510(k)

CLEANAIR/ CLEANWATER UNIT, MODEL 1600

K-Number: K003265 · 2000-12-22

ApplicantTexas Institute For Conservative Dentistry

Decision Date2000-12-22

Product CodeEIA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CLEANAIR/ CLEANWATER UNIT, MODEL 1600 is the device name listed in this FDA 510(k) record. The listed applicant is Texas Institute For Conservative Dentistry. It received FDA 510(k) clearance on 2000-12-22 under 510(k) number K003265. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEANAIR/ CLEANWATER UNIT, MODEL 1600?

CLEANAIR/ CLEANWATER UNIT, MODEL 1600 is a medical device that received FDA 510(k) clearance on 2000-12-22. The listed applicant is Texas Institute For Conservative Dentistry. The 510(k) number is K003265.

When did CLEANAIR/ CLEANWATER UNIT, MODEL 1600 receive FDA 510(k) clearance?

CLEANAIR/ CLEANWATER UNIT, MODEL 1600 received FDA 510(k) clearance on 2000-12-22, under 510(k) number K003265.

Who is the listed applicant for CLEANAIR/ CLEANWATER UNIT, MODEL 1600?

The FDA 510(k) record lists Texas Institute For Conservative Dentistry as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEANAIR/ CLEANWATER UNIT, MODEL 1600?

The FDA product code for CLEANAIR/ CLEANWATER UNIT, MODEL 1600 is EIA.

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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.