FDA 510(k)

STB GUEDEL AIRWAY

K-Number: K933760 · 1994-03-23

ApplicantSave-T-Breath Distributors C.C.

Decision Date1994-03-23

Product CodeCAE

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

STB GUEDEL AIRWAY is the device name listed in this FDA 510(k) record. The listed applicant is Save-T-Breath Distributors C.C.. It received FDA 510(k) clearance on 1994-03-23 under 510(k) number K933760. 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 STB GUEDEL AIRWAY?

STB GUEDEL AIRWAY is a medical device that received FDA 510(k) clearance on 1994-03-23. The listed applicant is Save-T-Breath Distributors C.C.. The 510(k) number is K933760.

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

STB GUEDEL AIRWAY received FDA 510(k) clearance on 1994-03-23, under 510(k) number K933760.

Who is the listed applicant for STB GUEDEL AIRWAY?

The FDA 510(k) record lists Save-T-Breath Distributors C.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STB GUEDEL AIRWAY?

The FDA product code for STB GUEDEL AIRWAY is CAE.

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 Save-T-Breath Distributors C.C. as applicant

K933763SAVE-T-BREATH AMBILICAL CORD CLAMP K933762STB YANKAUER SUCKER/NOZZLE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.