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FDA 510(k)

CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE

K-Number: K072295 · 2007-10-11

ApplicantOridion Capnography, Inc.
Decision Date2007-10-11
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE 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 2007-10-11 under 510(k) number K072295. 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 CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE?

CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE is a medical device that received FDA 510(k) clearance on 2007-10-11. The listed applicant is Oridion Capnography, Inc.. The 510(k) number is K072295.

When did CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE receive FDA 510(k) clearance?

CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE received FDA 510(k) clearance on 2007-10-11, under 510(k) number K072295.

Who is the listed applicant for CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE?

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 CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE?

The FDA product code for CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE is DQA.

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Other records listing Oridion Capnography, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K101995CAPNOSTREAM 20P WITH MASIMO SPO2 BOARDK094012CAPNOSTREAM20 WITH MICROMEDICO2 MODULEK082268CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEXK060065CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR

Related Devices (Code: DQA)

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Official Source

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