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FDA 510(k)

CENTURY COLOR TRACE

K-Number: K884152 · 1988-12-15

ApplicantBiomedical Systems, Inc.
Decision Date1988-12-15
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CENTURY COLOR TRACE is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Systems, Inc.. It received FDA 510(k) clearance on 1988-12-15 under 510(k) number K884152. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTURY COLOR TRACE?

CENTURY COLOR TRACE is a medical device that received FDA 510(k) clearance on 1988-12-15. The listed applicant is Biomedical Systems, Inc.. The 510(k) number is K884152.

When did CENTURY COLOR TRACE receive FDA 510(k) clearance?

CENTURY COLOR TRACE received FDA 510(k) clearance on 1988-12-15, under 510(k) number K884152.

Who is the listed applicant for CENTURY COLOR TRACE?

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

What is the FDA product code for CENTURY COLOR TRACE?

The FDA product code for CENTURY COLOR TRACE is DSI.

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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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