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FDA 510(k)

TRAUMA CARE EVALUATION

K-Number: K843905 · 1985-09-26

ApplicantQuantitative
Decision Date1985-09-26
Product CodePLB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRAUMA CARE EVALUATION is the device name listed in this FDA 510(k) record. The listed applicant is Quantitative. It received FDA 510(k) clearance on 1985-09-26 under 510(k) number K843905. The device is classified under product code PLB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUMA CARE EVALUATION?

TRAUMA CARE EVALUATION is a medical device that received FDA 510(k) clearance on 1985-09-26. The listed applicant is Quantitative. The 510(k) number is K843905.

When did TRAUMA CARE EVALUATION receive FDA 510(k) clearance?

TRAUMA CARE EVALUATION received FDA 510(k) clearance on 1985-09-26, under 510(k) number K843905.

Who is the listed applicant for TRAUMA CARE EVALUATION?

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

What is the FDA product code for TRAUMA CARE EVALUATION?

The FDA product code for TRAUMA CARE EVALUATION is PLB.

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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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