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FDA 510(k)

IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID

K-Number: K964271 · 1997-12-19

ApplicantAirel-West
Decision Date1997-12-19
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID is the device name listed in this FDA 510(k) record. The listed applicant is Airel-West. It received FDA 510(k) clearance on 1997-12-19 under 510(k) number K964271. 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 IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID?

IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID is a medical device that received FDA 510(k) clearance on 1997-12-19. The listed applicant is Airel-West. The 510(k) number is K964271.

When did IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID receive FDA 510(k) clearance?

IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID received FDA 510(k) clearance on 1997-12-19, under 510(k) number K964271.

Who is the listed applicant for IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID?

The FDA 510(k) record lists Airel-West as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID?

The FDA product code for IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID 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.

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