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FDA 510(k)

EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)

K-Number: K063167 · 2007-02-06

ApplicantPhasein AB
Decision Date2007-02-06
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) is the device name listed in this FDA 510(k) record. The listed applicant is Phasein AB. It received FDA 510(k) clearance on 2007-02-06 under 510(k) number K063167. 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 EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)?

EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) is a medical device that received FDA 510(k) clearance on 2007-02-06. The listed applicant is Phasein AB. The 510(k) number is K063167.

When did EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) receive FDA 510(k) clearance?

EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) received FDA 510(k) clearance on 2007-02-06, under 510(k) number K063167.

Who is the listed applicant for EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)?

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 EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)?

The FDA product code for EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) is CCK.

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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 200601K103604ISA CO2, ISA AX+, ISA OR+K081601VEO MULTIGAS MONITOR FOR POCKET PCK072813EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & 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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