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FDA 510(k)

D/SENSE 1-STEP

K-Number: K021146 · 2002-07-02

ApplicantCentrix, Inc.
Decision Date2002-07-02
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

D/SENSE 1-STEP is the device name listed in this FDA 510(k) record. The listed applicant is Centrix, Inc.. It received FDA 510(k) clearance on 2002-07-02 under 510(k) number K021146. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D/SENSE 1-STEP?

D/SENSE 1-STEP is a medical device that received FDA 510(k) clearance on 2002-07-02. The listed applicant is Centrix, Inc.. The 510(k) number is K021146.

When did D/SENSE 1-STEP receive FDA 510(k) clearance?

D/SENSE 1-STEP received FDA 510(k) clearance on 2002-07-02, under 510(k) number K021146.

Who is the listed applicant for D/SENSE 1-STEP?

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

What is the FDA product code for D/SENSE 1-STEP?

The FDA product code for D/SENSE 1-STEP is EJK.

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Related Devices (Code: EJK)

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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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