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FDA 510(k)

SENSITESTER

K-Number: K871167 · 1987-04-01

ApplicantDexin Pty. , Ltd.
Decision Date1987-04-01
Product CodeGWY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SENSITESTER is the device name listed in this FDA 510(k) record. The listed applicant is Dexin Pty. , Ltd.. It received FDA 510(k) clearance on 1987-04-01 under 510(k) number K871167. The device is classified under product code GWY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSITESTER?

SENSITESTER is a medical device that received FDA 510(k) clearance on 1987-04-01. The listed applicant is Dexin Pty. , Ltd.. The 510(k) number is K871167.

When did SENSITESTER receive FDA 510(k) clearance?

SENSITESTER received FDA 510(k) clearance on 1987-04-01, under 510(k) number K871167.

Who is the listed applicant for SENSITESTER?

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

What is the FDA product code for SENSITESTER?

The FDA product code for SENSITESTER is GWY.

Related Clinical Trials

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Related Devices (Code: GWY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K050313BIS SRS (SEMI-RESUABLE SENSOR)Aspect Medical Systems, Inc.K942926NEURO-AIDEBurke Neutech, Inc.K8517491-380 PINWHEEL (WARTENBERG)ArtiberiaK780422PINWHEELProjects IN Health

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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