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FDA 510(k)

AIRWAYS

K-Number: K820709 · 1982-06-25

ApplicantSeven Harvest Intl. Import & Export
Decision Date1982-06-25
Product CodeCAE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRWAYS is the device name listed in this FDA 510(k) record. The listed applicant is Seven Harvest Intl. Import & Export. It received FDA 510(k) clearance on 1982-06-25 under 510(k) number K820709. 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 AIRWAYS?

AIRWAYS is a medical device that received FDA 510(k) clearance on 1982-06-25. The listed applicant is Seven Harvest Intl. Import & Export. The 510(k) number is K820709.

When did AIRWAYS receive FDA 510(k) clearance?

AIRWAYS received FDA 510(k) clearance on 1982-06-25, under 510(k) number K820709.

Who is the listed applicant for AIRWAYS?

The FDA 510(k) record lists Seven Harvest Intl. Import & Export as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIRWAYS?

The FDA product code for AIRWAYS is CAE.

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Other records listing Seven Harvest Intl. Import & Export 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.

K940793DOUBLE TRACH SWIVEL CONNECTORK823506NASAL CANNULAK823143BUBBLE HUMIDIFIERSK823141OXYGEN MASKSK823142OXYGEN TUBINGSK813074CONNECTORS & ADAPTERS

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Related Devices (Code: CAE)

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.

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 MedicalK960240RUSCH 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.

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