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FDA 510(k)

MODIFIED SPIROSCAN 1000

K-Number: K897094 · 1990-01-12

ApplicantFukuda Denshi USA, Inc.
Decision Date1990-01-12
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED SPIROSCAN 1000 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 1990-01-12 under 510(k) number K897094. 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 MODIFIED SPIROSCAN 1000?

MODIFIED SPIROSCAN 1000 is a medical device that received FDA 510(k) clearance on 1990-01-12. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K897094.

When did MODIFIED SPIROSCAN 1000 receive FDA 510(k) clearance?

MODIFIED SPIROSCAN 1000 received FDA 510(k) clearance on 1990-01-12, under 510(k) number K897094.

Who is the listed applicant for MODIFIED SPIROSCAN 1000?

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 MODIFIED SPIROSCAN 1000?

The FDA product code for MODIFIED SPIROSCAN 1000 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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