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Quanta Blood Pressure Meter, Model: Cardiac Elite 1000 or QH200

by Quanta Computer, Inc.

510(k) K083078

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 NumberK083078 Date26 Nov 2008ClearedStatusActive

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  • Withdrawn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
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
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 Quanta Blood Pressure Meter, Model: Cardiac Elite 1000 or QH200 is a medical device designed to measure systolic and diastolic blood pressure. It also functions to measure the pulse rate of the user.

This device is identified by K number K083078 and has received FDA 510(k) clearance. It is classified as a Class 2 device under the cardiovascular advisory committee.

Other devices from Quanta Computer, 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 Quanta Cardiac Elite 1000?

    The Quanta Cardiac Elite 1000, also known as the QH200, is a medical device engineered to measure a user's systolic and diastolic blood pressure. Additionally, the device is capable of measuring the user's pulse rate.

  • What is the regulatory status of this blood pressure meter?

    This device has received FDA 510(k) clearance under K number K083078. It is classified as a Class 2 device and was determined to be substantially equivalent to existing devices by the cardiovascular advisory committee.

  • How is the Quanta Cardiac Elite 1000 classified for regulatory purposes?

    The device is classified as a Class 2 medical device. It falls under the cardiovascular advisory committee and is identified by the product code DXN, reflecting its intended use for blood pressure and pulse monitoring.