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FDA 510(k)

PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4

K-Number: K844873 · 1985-02-21

ApplicantPennine Medical , Ltd.
Decision Date1985-02-21
Product CodeCAE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4 is the device name listed in this FDA 510(k) record. The listed applicant is Pennine Medical , Ltd.. It received FDA 510(k) clearance on 1985-02-21 under 510(k) number K844873. 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 PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4?

PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4 is a medical device that received FDA 510(k) clearance on 1985-02-21. The listed applicant is Pennine Medical , Ltd.. The 510(k) number is K844873.

When did PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4 receive FDA 510(k) clearance?

PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4 received FDA 510(k) clearance on 1985-02-21, under 510(k) number K844873.

Who is the listed applicant for PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4?

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

What is the FDA product code for PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4?

The FDA product code for PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4 is CAE.

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Other records listing Pennine Medical , Ltd. 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.

K854443O'NEIL URINARY CATHETER INTRODUCERK852859PENNINE CONNECTING TUBINGK852081PENNINE OXYGEN LINK TUBINGK844874PENNINE LINK YANKAUERSK844876PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,K852079PENNINE DERBY YANKAUER

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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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