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FDA 510(k)

AS/3 NETWORK LINK

K-Number: K953006 · 1995-09-27

ApplicantDatex Medical Instrumentation, Inc.
Decision Date1995-09-27
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AS/3 NETWORK LINK is the device name listed in this FDA 510(k) record. The listed applicant is Datex Medical Instrumentation, Inc.. It received FDA 510(k) clearance on 1995-09-27 under 510(k) number K953006. 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 AS/3 NETWORK LINK?

AS/3 NETWORK LINK is a medical device that received FDA 510(k) clearance on 1995-09-27. The listed applicant is Datex Medical Instrumentation, Inc.. The 510(k) number is K953006.

When did AS/3 NETWORK LINK receive FDA 510(k) clearance?

AS/3 NETWORK LINK received FDA 510(k) clearance on 1995-09-27, under 510(k) number K953006.

Who is the listed applicant for AS/3 NETWORK LINK?

The FDA 510(k) record lists Datex Medical Instrumentation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AS/3 NETWORK LINK?

The FDA product code for AS/3 NETWORK LINK is CCK.

Related Clinical Trials

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.

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Other records listing Datex Medical Instrumentation, Inc. 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.

K955026AS/3 NMT MODULEK961063AS/3 CARDIAC OUTPUT & SVO2 MODULEK960490AS/3 COMPACT AIRWAY MODULE M-CAIOVK912530CARDIOCAP II(TM)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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