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FDA 510(k)

SMART BITEBLOC

K-Number: K042665 · 2004-11-23

ApplicantOridion Medical 1987 , Ltd.
Decision Date2004-11-23
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SMART BITEBLOC 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 2004-11-23 under 510(k) number K042665. 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 SMART BITEBLOC?

SMART BITEBLOC is a medical device that received FDA 510(k) clearance on 2004-11-23. The listed applicant is Oridion Medical 1987 , Ltd.. The 510(k) number is K042665.

When did SMART BITEBLOC receive FDA 510(k) clearance?

SMART BITEBLOC received FDA 510(k) clearance on 2004-11-23, under 510(k) number K042665.

Who is the listed applicant for SMART BITEBLOC?

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 SMART BITEBLOC?

The FDA product code for SMART BITEBLOC 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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