Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD

K-Number: K101995 · 2011-01-11

ApplicantOridion Capnography, Inc.
Decision Date2011-01-11
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD 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 2011-01-11 under 510(k) number K101995. 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 20P WITH MASIMO SPO2 BOARD?

CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD is a medical device that received FDA 510(k) clearance on 2011-01-11. The listed applicant is Oridion Capnography, Inc.. The 510(k) number is K101995.

When did CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD receive FDA 510(k) clearance?

CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD received FDA 510(k) clearance on 2011-01-11, under 510(k) number K101995.

Who is the listed applicant for CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD?

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 20P WITH MASIMO SPO2 BOARD?

The FDA product code for CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD is DQA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K094012CAPNOSTREAM20 WITH MICROMEDICO2 MODULEK082268CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEXK072295CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWAREK060065CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR

Related Devices (Code: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse 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 SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

View on FDA Database →

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

↑