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Battery Operated Flow Rate Computer

by 3M Health Care, Sarns

510(k) K760756

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 NumberK760756 Date15 Oct 1976ClearedStatusActive

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  • Withdrawn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
DXG
Device Class
Class II
Regulation
21 CFR Part 870.1435
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Battery Operated Flow Rate Computer is a diagnostic, pre-programmed, single-function computer designed for cardiovascular applications. It functions to calculate and monitor flow rate data during clinical procedures.

This device is manufactured by 3M Health Care, Sarns and has received FDA 510(k) clearance under the reference number K760756. It is classified as a Class 2 medical device under regulation number 870.1435.

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Questions

AI-generated answers, 27 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 Battery Operated Flow Rate Computer?

    This device is a pre-programmed, single-function computer designed specifically for cardiovascular applications. Its primary purpose is to calculate and monitor flow rate data during clinical procedures.

  • What is the regulatory status of this device?

    The device has received FDA 510(k) clearance under the reference number K760756. It is classified as a Class 2 medical device under regulation number 870.1435.

  • Who is the manufacturer of this flow rate computer?

    This device is manufactured by 3M Health Care, Sarns, based in McHenry, Illinois.