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FDA 510(k)

'HILT-WAY' RESUSCITATOR

K-Number: K880241 · 1988-03-31

ApplicantMedifield , Ltd.
Decision Date1988-03-31
Product CodeCAE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

'HILT-WAY' RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medifield , Ltd.. It received FDA 510(k) clearance on 1988-03-31 under 510(k) number K880241. 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 'HILT-WAY' RESUSCITATOR?

'HILT-WAY' RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1988-03-31. The listed applicant is Medifield , Ltd.. The 510(k) number is K880241.

When did 'HILT-WAY' RESUSCITATOR receive FDA 510(k) clearance?

'HILT-WAY' RESUSCITATOR received FDA 510(k) clearance on 1988-03-31, under 510(k) number K880241.

Who is the listed applicant for 'HILT-WAY' RESUSCITATOR?

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

What is the FDA product code for 'HILT-WAY' RESUSCITATOR?

The FDA product code for 'HILT-WAY' RESUSCITATOR is CAE.

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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

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

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