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Biosensor Asc System

by Biosensor Corp.

510(k) K831676

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 NumberK831676 Date1 Dec 1983ClearedStatusActive

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  • Withdrawn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
DSI
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Biosensor Asc System is an arrhythmia detector and alarm device. It is designed to monitor an electrocardiogram and produce a visible or audible signal when an arrhythmia is detected.

This device is classified as a class 2 medical device under regulation 870.1025. It received FDA 510(k) clearance on December 1, 1983, under the traditional clearance type.

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Questions

AI-generated answers, 25 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 Biosensor Asc System?

    The Biosensor Asc System is designed to monitor an electrocardiogram and produce a visible or audible signal when an arrhythmia is detected.

  • How is this device classified for regulatory purposes?

    The Biosensor Asc System is classified as a class 2 medical device under regulation 870.1025.

  • What is the regulatory history of this device?

    The device received FDA 510(k) clearance on December 1, 1983, under the traditional clearance type, with a decision description of substantially equivalent.