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FDA 510(k)

MODIFIED FEF(TM) END-TIDAL CO2 DETECTOR

K-Number: K884080 · 1988-10-21

ApplicantFenem, Inc.
Decision Date1988-10-21
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED 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 1988-10-21 under 510(k) number K884080. 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 MODIFIED FEF(TM) END-TIDAL CO2 DETECTOR?

MODIFIED FEF(TM) END-TIDAL CO2 DETECTOR is a medical device that received FDA 510(k) clearance on 1988-10-21. The listed applicant is Fenem, Inc.. The 510(k) number is K884080.

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

MODIFIED FEF(TM) END-TIDAL CO2 DETECTOR received FDA 510(k) clearance on 1988-10-21, under 510(k) number K884080.

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

The FDA product code for MODIFIED 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.

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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 DETECTORK883950MODIFIED TOOB-CHEQ CARBON DIOXIDE GAS ANALYZERK883821FEF(TM) END-TIDAL CO2 DETECTOR

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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