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FDA 510(k)

ACCUTRAX, MODEL EPF840

K-Number: K982995 · 1998-12-04

ApplicantKorr Medical Technologies, Inc.
Decision Date1998-12-04
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ACCUTRAX, MODEL EPF840 is the device name listed in this FDA 510(k) record. The listed applicant is Korr Medical Technologies, Inc.. It received FDA 510(k) clearance on 1998-12-04 under 510(k) number K982995. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUTRAX, MODEL EPF840?

ACCUTRAX, MODEL EPF840 is a medical device that received FDA 510(k) clearance on 1998-12-04. The listed applicant is Korr Medical Technologies, Inc.. The 510(k) number is K982995.

When did ACCUTRAX, MODEL EPF840 receive FDA 510(k) clearance?

ACCUTRAX, MODEL EPF840 received FDA 510(k) clearance on 1998-12-04, under 510(k) number K982995.

Who is the listed applicant for ACCUTRAX, MODEL EPF840?

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

What is the FDA product code for ACCUTRAX, MODEL EPF840?

The FDA product code for ACCUTRAX, MODEL EPF840 is BZH.

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Other records listing Korr Medical Technologies, 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.

K021490REEVUE INDIRECT CALORIMETER, MODEL#8100

Related Devices (Code: BZH)

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

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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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