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FDA 510(k)

ISA CO2, ISA AX+, ISA OR+

K-Number: K103604 · 2011-04-06

ApplicantPhasein AB
Decision Date2011-04-06
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ISA CO2, ISA AX+, ISA OR+ is the device name listed in this FDA 510(k) record. The listed applicant is Phasein AB. It received FDA 510(k) clearance on 2011-04-06 under 510(k) number K103604. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISA CO2, ISA AX+, ISA OR+?

ISA CO2, ISA AX+, ISA OR+ is a medical device that received FDA 510(k) clearance on 2011-04-06. The listed applicant is Phasein AB. The 510(k) number is K103604.

When did ISA CO2, ISA AX+, ISA OR+ receive FDA 510(k) clearance?

ISA CO2, ISA AX+, ISA OR+ received FDA 510(k) clearance on 2011-04-06, under 510(k) number K103604.

Who is the listed applicant for ISA CO2, ISA AX+, ISA OR+?

The FDA 510(k) record lists Phasein AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISA CO2, ISA AX+, ISA OR+?

The FDA product code for ISA CO2, ISA AX+, ISA OR+ is CCK.

Other records listing Phasein AB 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.

K123043IRMA C02 MODEL 200101; IRMA AX 200601K081601VEO MULTIGAS MONITOR FOR POCKET PCK072813EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG)K063167EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)

Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.

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.

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