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FDA 510(k)

ACCU-TRAC

K-Number: K843055 · 1985-05-28

ApplicantOlympic Medical Corp.
Decision Date1985-05-28
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCU-TRAC is the device name listed in this FDA 510(k) record. The listed applicant is Olympic Medical Corp.. It received FDA 510(k) clearance on 1985-05-28 under 510(k) number K843055. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-TRAC?

ACCU-TRAC is a medical device that received FDA 510(k) clearance on 1985-05-28. The listed applicant is Olympic Medical Corp.. The 510(k) number is K843055.

When did ACCU-TRAC receive FDA 510(k) clearance?

ACCU-TRAC received FDA 510(k) clearance on 1985-05-28, under 510(k) number K843055.

Who is the listed applicant for ACCU-TRAC?

The FDA 510(k) record lists Olympic Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCU-TRAC?

The FDA product code for ACCU-TRAC is DXN.

Other records listing Olympic Medical Corp. as applicant

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Related Devices (Code: DXN)

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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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