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FDA 510(k)

GAS TRAK PLUS

K-Number: K884977 · 1989-01-27

ApplicantUnited Diagnostics, Inc.
Decision Date1989-01-27
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAS TRAK PLUS is the device name listed in this FDA 510(k) record. The listed applicant is United Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-01-27 under 510(k) number K884977. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAS TRAK PLUS?

GAS TRAK PLUS is a medical device that received FDA 510(k) clearance on 1989-01-27. The listed applicant is United Diagnostics, Inc.. The 510(k) number is K884977.

When did GAS TRAK PLUS receive FDA 510(k) clearance?

GAS TRAK PLUS received FDA 510(k) clearance on 1989-01-27, under 510(k) number K884977.

Who is the listed applicant for GAS TRAK PLUS?

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

What is the FDA product code for GAS TRAK PLUS?

The FDA product code for GAS TRAK PLUS is JJY.

Other records listing United Diagnostics, Inc. as applicant

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.

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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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