FDA 510(k)

AIRWAY MASKS

K-Number: K832512 · 1984-01-17

ApplicantArtec Environmental Monitoring Division

Decision Date1984-01-17

Product CodeCAE

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

AIRWAY MASKS is the device name listed in this FDA 510(k) record. The listed applicant is Artec Environmental Monitoring Division. It received FDA 510(k) clearance on 1984-01-17 under 510(k) number K832512. The device is classified under product code CAE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRWAY MASKS?

AIRWAY MASKS is a medical device that received FDA 510(k) clearance on 1984-01-17. The listed applicant is Artec Environmental Monitoring Division. The 510(k) number is K832512.

When did AIRWAY MASKS receive FDA 510(k) clearance?

AIRWAY MASKS received FDA 510(k) clearance on 1984-01-17, under 510(k) number K832512.

Who is the listed applicant for AIRWAY MASKS?

The FDA 510(k) record lists Artec Environmental Monitoring Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIRWAY MASKS?

The FDA product code for AIRWAY MASKS is CAE.

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Other records listing Artec Environmental Monitoring Division as applicant

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Related Devices (Code: CAE)

K033189KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305King Systems Corp.K033186KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205King Systems Corp.K021634KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105King Systems Corp.K955721CUFFED OROPHARYNGEAL AIRWAY (COPA)Mallinckrodt Medical K960240RUSCH OPTOSAFERusch Intl.K950613KEISEIKeisei (Usa) Co., Ltd.

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.