Pressure Monitor

FDA 510(k) K842194 · Norton Texas Medical Products

Substantially Equivalent

510(k) numberK842194

Submission

Device name
Pressure Monitor
Applicant
Norton Texas Medical Products
Mchenry, IL, US
Received
June 4, 1984
Decision date
August 27, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXS – Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4310
Specialty
Cardiovascular

Other 510(k)s with product code DXS

510(k)DeviceApplicantDecision
K113235Pressure Display Box,Dlp Disposable Pressure Display Sets-Non Sterile VersionsDXS · Special Medtronic, Inc.12/02/2011SE
K944764Vti Disposable Pressure Display SetDXS · Traditional Vascular Technology Incorporated12/27/1994SE
K912045TMP Pressure Isolatorr, TMP Pressure Monitor SystDXS · Traditional Lifestream Int'L, Inc.10/31/1991SE
K900797Stockert Shiley Dual Pressure Control Module XRDXS · Traditional Shiley, Inc.05/10/1990SE
K873802Pressure Barrier Kit Cat. No. PBK-3DXS · Traditional American Omni Medical, Inc.11/06/1987SE
K862836Stockert-Shiley Caps and Caps Dual Pressure ModuleDXS · Traditional Shiley, Inc.09/12/1986SE
K852232Pressure Display Box #60000/TUBING Set #61000DXS · Traditional Dlp, Inc.08/09/1985SE
K831750PM-3DXS · Traditional Delta Medical Industries07/26/1983SE
K822822Gambro Pressure Monitor PRM 10DXS · Traditional Gambro, Inc.10/18/1982SE
K820912PMS-2 Pressure Monitor SeparatorDXS · Traditional Delta Medical Industries05/18/1982SE

More from Delta Medical Industries

510(k)DeviceDecision
K843983Myocardial InsulatorDTR · Traditional 12/27/1984SE
K842992Grasshopper - RetractorGAD · Traditional 08/17/1984SE
K832517Custom Kwik Set And/Or PakJOL · Traditional 10/14/1983SE

Questions and answers

When was Pressure Monitor cleared by the FDA?

Pressure Monitor (K842194) received a 510(k) decision of Substantially Equivalent on August 27, 1984, 84 days after the submission was received.

What is the product code of K842194?

The FDA product code is DXS – Gauge, Pressure, Coronary, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4310.