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FDA 510(k)

MICROSTREAM EXTERNAL BATTERY CHARGER

K-Number: K002163 · 2001-01-11

ApplicantOridion Medical 1987 , Ltd.
Decision Date2001-01-11
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICROSTREAM EXTERNAL BATTERY CHARGER is the device name listed in this FDA 510(k) record. The listed applicant is Oridion Medical 1987 , Ltd.. It received FDA 510(k) clearance on 2001-01-11 under 510(k) number K002163. 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 MICROSTREAM EXTERNAL BATTERY CHARGER?

MICROSTREAM EXTERNAL BATTERY CHARGER is a medical device that received FDA 510(k) clearance on 2001-01-11. The listed applicant is Oridion Medical 1987 , Ltd.. The 510(k) number is K002163.

When did MICROSTREAM EXTERNAL BATTERY CHARGER receive FDA 510(k) clearance?

MICROSTREAM EXTERNAL BATTERY CHARGER received FDA 510(k) clearance on 2001-01-11, under 510(k) number K002163.

Who is the listed applicant for MICROSTREAM EXTERNAL BATTERY CHARGER?

The FDA 510(k) record lists Oridion Medical 1987 , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROSTREAM EXTERNAL BATTERY CHARGER?

The FDA product code for MICROSTREAM EXTERNAL BATTERY CHARGER is CCK.

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Other records listing Oridion Medical 1987 , Ltd. as applicant

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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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