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FDA 510(k)

SPIROSIFT 500A

K-Number: K904200 · 1991-05-22

ApplicantFukuda Denshi USA, Inc.
Decision Date1991-05-22
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROSIFT 500A is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 1991-05-22 under 510(k) number K904200. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIROSIFT 500A?

SPIROSIFT 500A is a medical device that received FDA 510(k) clearance on 1991-05-22. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K904200.

When did SPIROSIFT 500A receive FDA 510(k) clearance?

SPIROSIFT 500A received FDA 510(k) clearance on 1991-05-22, under 510(k) number K904200.

Who is the listed applicant for SPIROSIFT 500A?

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

What is the FDA product code for SPIROSIFT 500A?

The FDA product code for SPIROSIFT 500A is BZG.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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