FDA 510(k)

DISPOSABLE GUEDEL AIRWAY

K-Number: K850248 · 1985-03-12

Decision Date1985-03-12

Product CodeCAE

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE GUEDEL AIRWAY is the device name listed in this FDA 510(k) record. The listed applicant is Inmed Corp.. It received FDA 510(k) clearance on 1985-03-12 under 510(k) number K850248. 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 DISPOSABLE GUEDEL AIRWAY?

DISPOSABLE GUEDEL AIRWAY is a medical device that received FDA 510(k) clearance on 1985-03-12. The listed applicant is Inmed Corp.. The 510(k) number is K850248.

When did DISPOSABLE GUEDEL AIRWAY receive FDA 510(k) clearance?

DISPOSABLE GUEDEL AIRWAY received FDA 510(k) clearance on 1985-03-12, under 510(k) number K850248.

Who is the listed applicant for DISPOSABLE GUEDEL AIRWAY?

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

What is the FDA product code for DISPOSABLE GUEDEL AIRWAY?

The FDA product code for DISPOSABLE GUEDEL AIRWAY is CAE.

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Other records listing Inmed Corp. as applicant

K862672ESOPHAGEAL STETHOSCOPE WITH THERMISTOR K853162STERILE NASOPHARYNGEAL AIRWAY K850152PRECONNECTED URETHRAL CATHETER TRAY K850335URETEROSCOPY CATHETER K844801ULTRA EXTERNAL CATHETER K842301DISPOSABLE LATEX BANDAGE

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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.