FDA 510(k)

CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR

K-Number: K060065 · 2006-05-04

Decision Date2006-05-04

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Oridion Capnography, Inc.. It received FDA 510(k) clearance on 2006-05-04 under 510(k) number K060065. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR?

CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR is a medical device that received FDA 510(k) clearance on 2006-05-04. The listed applicant is Oridion Capnography, Inc.. The 510(k) number is K060065.

When did CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR receive FDA 510(k) clearance?

CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR received FDA 510(k) clearance on 2006-05-04, under 510(k) number K060065.

Who is the listed applicant for CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR?

The FDA 510(k) record lists Oridion Capnography, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR?

The FDA product code for CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR is DQA.

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Other records listing Oridion Capnography, Inc. as applicant

K101995CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD K094012CAPNOSTREAM20 WITH MICROMEDICO2 MODULE K082268CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX K072295CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE

Related Devices (Code: DQA)

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin Systeme K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita Corporation K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.