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FDA 510(k)

POLARIS

K-Number: K950388 · 1995-05-02

ApplicantSpegas Industries, Ltd.
Decision Date1995-05-02
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POLARIS is the device name listed in this FDA 510(k) record. The listed applicant is Spegas Industries, Ltd.. It received FDA 510(k) clearance on 1995-05-02 under 510(k) number K950388. 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 POLARIS?

POLARIS is a medical device that received FDA 510(k) clearance on 1995-05-02. The listed applicant is Spegas Industries, Ltd.. The 510(k) number is K950388.

When did POLARIS receive FDA 510(k) clearance?

POLARIS received FDA 510(k) clearance on 1995-05-02, under 510(k) number K950388.

Who is the listed applicant for POLARIS?

The FDA 510(k) record lists Spegas Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLARIS?

The FDA product code for POLARIS is CCK.

Related Clinical Trials

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Other records listing Spegas Industries, Ltd. 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.

K964239COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZERK950387GEMINIK942849CAPNOSATK933707CAPNODIG

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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