Classic (TM) 200 Oxygen Flowmeter

FDA 510(k) K871452 · The Timeter Group

Substantially Equivalent

510(k) numberK871452

Submission

Device name
Classic (TM) 200 Oxygen Flowmeter
Applicant
The Timeter Group
Lancaster, PA, US
Received
April 13, 1987
Decision date
June 22, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CAX – Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Device class
Class I (low risk)
Regulation
21 CFR 868.2340
Specialty
Anesthesiology

Other 510(k)s with product code CAX

510(k)DeviceApplicantDecision
K923781MXR-2000 FlowmeterCAX · Traditional Porter Instrument Co., Inc.06/10/1993SE
K910316Ohmeda - Low Flow FlowmeterCAX · Traditional Ohmeda Medical04/12/1991SE
K884973FR6000 FlowmeterCAX · Traditional Key Instruments01/17/1989SE
K872718Series D FlowmeterCAX · Traditional Puritan Bennett Corp.08/05/1987SE
K862797Airco 2000 Series FlowmetersCAX · Traditional Airco, Inc.08/08/1986SE
K854067Select FlowmeterCAX · Traditional Precision Medical, Inc.10/29/1985SE
K851288Oxygen Delivery Measuring DeviceCAX · Traditional Bar-Dix, Inc.09/03/1985SE
K850559Pressure Relief AdaptorCAX · Traditional Precision Medical, Inc.04/25/1985SE
K850560Flowmeter, Backpressure Compensated, Thorpe TubeCAX · Traditional Precision Medical, Inc.04/17/1985SE
K834260RECON-2 Flow ControllerCAX · Traditional Precision Metering, Inc.01/10/1984SE

More from Precision Metering, Inc.

510(k)DeviceDecision
K862171MP-500 Electronic NebulizerKFZ · Traditional 07/14/1986SE
K852374Oxygen Regulators #50 PRT & BGT(BGT15,BGT18CAN · Traditional 07/12/1985SE
K844556KHM 2000 Drip WatcherFLN · Traditional 01/14/1985SE

Questions and answers

When was Classic (TM) 200 Oxygen Flowmeter cleared by the FDA?

Classic (TM) 200 Oxygen Flowmeter (K871452) received a 510(k) decision of Substantially Equivalent on June 22, 1987, 70 days after the submission was received.

What is the product code of K871452?

The FDA product code is CAX – Flowmeter, Tube, Thorpe, Back-Pressure Compensated, a Class I (low risk) device regulated under 21 CFR 868.2340.