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Universal Computer Interface System

by Vacumetrics, Inc.

510(k) K851706

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 NumberK851706 Date3 May 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  • Withdrawn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
BZM
Device Class
Class II
Regulation
21 CFR Part 868.1900
Advisory Committee
Anesthesiology
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 Universal Computer Interface System is a calculator and pulmonary function interpretor designed for diagnostic use. It functions as a device that facilitates human-computer interaction without the need for traditional input devices.

This device is classified as a Class 2 medical device under regulation number 868.1900. It received FDA 510(k) clearance on May 3, 1985, under the K851706 submission.

Other devices from Vacumetrics, Inc.

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 Universal Computer Interface System?

    This device serves as a calculator and pulmonary function interpreter intended for diagnostic use. It is specifically designed to facilitate human-computer interaction, allowing for data processing without the requirement of traditional input devices.

  • What is the regulatory classification of this device?

    The Universal Computer Interface System is classified as a Class 2 medical device under regulation number 868.1900. It received FDA 510(k) clearance on May 3, 1985, under submission number K851706.

  • Which medical specialty is this device associated with?

    The device is categorized under the Anesthesiology medical specialty, as indicated by its product code BZM and its review by the Anesthesiology advisory committee.