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Crit-Scan

by Noninvasive Medical Technology Corp.

510(k) K910077

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK910077 Date2 Jun 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Crit-Scan is a blood monitoring device. It is designed to provide noninvasive monitoring of blood parameters.

This device is identified by FDA 510(k) number K910077. It received FDA 510(k) clearance on June 2, 1992.

Other devices from Noninvasive Medical Technology Corp.

  • Crit-Line

    Class II

Questions

AI-generated answers, 22 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 primary function of the Crit-Scan?

    The Crit-Scan is a medical device engineered to provide noninvasive monitoring of blood parameters, allowing for clinical assessment without the need for invasive procedures.

  • What is the regulatory status of this device?

    The Crit-Scan received FDA 510(k) clearance on June 2, 1992, under the submission number K910077. It was determined to be substantially equivalent to existing devices by the FDA.

  • Who is the manufacturer of the Crit-Scan?

    The device is manufactured by Noninvasive Medical Technology Corp., located in Ogden, Utah, with the primary contact listed as Robert R. Steuer.