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FDA 510(k)

JANUS ATAC ENG ANALYSIS SYSTEM

K-Number: K904385 · 1992-06-10

ApplicantLife-Tech Intl., Inc.
Decision Date1992-06-10
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

JANUS ATAC ENG ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Intl., Inc.. It received FDA 510(k) clearance on 1992-06-10 under 510(k) number K904385. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JANUS ATAC ENG ANALYSIS SYSTEM?

JANUS ATAC ENG ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1992-06-10. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K904385.

When did JANUS ATAC ENG ANALYSIS SYSTEM receive FDA 510(k) clearance?

JANUS ATAC ENG ANALYSIS SYSTEM received FDA 510(k) clearance on 1992-06-10, under 510(k) number K904385.

Who is the listed applicant for JANUS ATAC ENG ANALYSIS SYSTEM?

The FDA 510(k) record lists Life-Tech Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JANUS ATAC ENG ANALYSIS SYSTEM?

The FDA product code for JANUS ATAC ENG ANALYSIS SYSTEM is GWN.

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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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