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Trauma Care Evaluation

by Quantitative

510(k) K843905

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843905 Date26 Sep 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PLB
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Trauma Care Evaluation is a device classified under Multivariate Vital Signs Index, intended for cardiovascular medical specialty. It is designed to assess vital signs in trauma care scenarios.

This device is regulated under FDA 510(k) clearance with a Traditional review type. It is not specified as single-use or reusable, and no storage or sterility details are provided in the specifications.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Trauma Care Evaluation device used for?

    The Trauma Care Evaluation is a Multivariate Vital Signs Index designed to assess vital signs in trauma care scenarios.

  • What is the regulatory status of this device?

    This device is regulated under FDA 510(k) clearance with a Traditional review type.

  • Is the device classified as single-use or reusable?

    The specifications do not specify whether the device is single-use or reusable.

  • What is the device's medical specialty?

    The device is intended for the cardiovascular medical specialty.