Digiflo Concentrator Analyzer

by Digiflo, Inc.

510(k) K072469

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

510(k) K072469↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK072469	Date3 Jan 2008Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K072469
FDA Product Code: CCL

Device Class: Class II
Regulation: 21 CFR Part 868.1720
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 Digiflo Concentrator Analyzer is a gas analyzer designed to measure oxygen purity and flow at the outlet of an oxygen concentrator. It is classified as a Class II medical device under product code CCL and regulation number 868.1720.

It is a portable, battery-operated diagnostic tool used by service personnel in hospitals, nursing homes, and repair centers. The device measures oxygen concentration and flow using ultrasonic wave transit-time and piezoresistive pressure transducers, and is supplied as a non-sterile, reusable instrument for professional service use.