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FDA 510(k)

FEF(TM) END-TIDAL CO2 DETECTOR

K-Number: K883821 · 1988-09-26

ApplicantFenem, Inc.
Decision Date1988-09-26
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FEF(TM) END-TIDAL CO2 DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Fenem, Inc.. It received FDA 510(k) clearance on 1988-09-26 under 510(k) number K883821. 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 FEF(TM) END-TIDAL CO2 DETECTOR?

FEF(TM) END-TIDAL CO2 DETECTOR is a medical device that received FDA 510(k) clearance on 1988-09-26. The listed applicant is Fenem, Inc.. The 510(k) number is K883821.

When did FEF(TM) END-TIDAL CO2 DETECTOR receive FDA 510(k) clearance?

FEF(TM) END-TIDAL CO2 DETECTOR received FDA 510(k) clearance on 1988-09-26, under 510(k) number K883821.

Who is the listed applicant for FEF(TM) END-TIDAL CO2 DETECTOR?

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

What is the FDA product code for FEF(TM) END-TIDAL CO2 DETECTOR?

The FDA product code for FEF(TM) END-TIDAL CO2 DETECTOR 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Fenem, 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.

K894429MODIFIED CLAIMS FOR FEF(TM) END-TIDAL CO2 DETECTORK8940532ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTORK884080MODIFIED FEF(TM) END-TIDAL CO2 DETECTORK883950MODIFIED TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER

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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