Paratrend 7 Intravascular Blood Gas Monitoring System

FDA 510(k) K953893 · Biomedical Sensors, Inc.

Substantially Equivalent

510(k) numberK953893

Submission

Device name
Paratrend 7 Intravascular Blood Gas Monitoring System
Applicant
Biomedical Sensors, Inc.
High Wycombe, Buckinghamshire, GB
Received
August 17, 1995
Decision date
November 4, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CCC – Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1150
Specialty
Anesthesiology

Other 510(k)s with product code CCC

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K071165Iscalert Sensor SystemCCC · Traditional Alertis Medical AS11/07/2007SE
K983198Trendcare Calibrator Model Scu 7007CCC · Traditional Diametrics Medical, Ltd.11/23/1999SE
K972314Paratrend 7 Neotrend Multiparameter/Sensor with Paratrend 7 Multiparameter Senior and…CCC · Traditional Diametrics Medical, Ltd.12/19/1997SE
K961790Point-Of-Care Blood Gas Monitor SystemCCC · Traditional Optical Sensors, Inc.04/09/1997SE
K963935Olympus Critical Care Monitoring SystemCCC · Traditional Optical Sensors, Inc.01/23/1997SE
K951094Point-Of-Care Arterial Blood Gas Monitoring SystemCCC · Traditional Optical Sensors, Inc.01/16/1996SE
K940188Paratrend 7 Satellite Intravascular Blood Gas Monitoring SystemCCC · Traditional Biomedical Sensors, Ltd.11/13/1995SE
K931185Sensicath Point-Of-Care Blood Gas Monitoring SysteCCC · Traditional Optical Sensors, Inc.10/21/1993SE
K901548Biomedical Sensors-Shiley BGM 4000 Intra Blood GasCCC · Traditional Shiley, Inc.01/14/1991SE
K891013Medtronic Intravascular Blood Gas MonitoringCCC · Traditional Medtronic Vascular08/02/1989SE

More from Medtronic Vascular

510(k)DeviceDecision
K940188Paratrend 7 Satellite Intravascular Blood Gas Monitoring SystemCCC · Traditional 11/13/1995SE
K862069Cardiomet 4000 Gas Monitoring SystemsDRY · Traditional 07/18/1986SE

Questions and answers

When was Paratrend 7 Intravascular Blood Gas Monitoring System cleared by the FDA?

Paratrend 7 Intravascular Blood Gas Monitoring System (K953893) received a 510(k) decision of Substantially Equivalent on November 4, 1997, 810 days after the submission was received.

What is the product code of K953893?

The FDA product code is CCC – Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1150.