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FDA 510(k)

VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA

K-Number: K063813 · 2008-03-26

ApplicantVentlab Corp.
Decision Date2008-03-26
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Ventlab Corp.. It received FDA 510(k) clearance on 2008-03-26 under 510(k) number K063813. 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 VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA?

VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA is a medical device that received FDA 510(k) clearance on 2008-03-26. The listed applicant is Ventlab Corp.. The 510(k) number is K063813.

When did VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA receive FDA 510(k) clearance?

VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA received FDA 510(k) clearance on 2008-03-26, under 510(k) number K063813.

Who is the listed applicant for VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA?

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

What is the FDA product code for VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA?

The FDA product code for VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA is CCK.

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Other records listing Ventlab Corp. as applicant

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K120118VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETERK102674CUFF SENTRYK093617VENTLAB 6000 SERIES HUMIDIFIERK093525ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHEK090840VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.K082204SERIES SY DISPOSABLE ELECTROSURGICAL PAD

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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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