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FDA 510(k)

PRIMA GUEDEL AIRWAYS

K-Number: K952013 · 1995-05-22

ApplicantPrima, Inc.
Decision Date1995-05-22
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRIMA GUEDEL AIRWAYS is the device name listed in this FDA 510(k) record. The listed applicant is Prima, Inc.. It received FDA 510(k) clearance on 1995-05-22 under 510(k) number K952013. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMA GUEDEL AIRWAYS?

PRIMA GUEDEL AIRWAYS is a medical device that received FDA 510(k) clearance on 1995-05-22. The listed applicant is Prima, Inc.. The 510(k) number is K952013.

When did PRIMA GUEDEL AIRWAYS receive FDA 510(k) clearance?

PRIMA GUEDEL AIRWAYS received FDA 510(k) clearance on 1995-05-22, under 510(k) number K952013.

Who is the listed applicant for PRIMA GUEDEL AIRWAYS?

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

What is the FDA product code for PRIMA GUEDEL AIRWAYS?

The FDA product code for PRIMA GUEDEL AIRWAYS is BTR.

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Other records listing Prima, Inc. 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.

K952011PRIMA BREATHING BAGSK952010PRIMA VENTILATOR HOSESK952022PRIMA VOLUMN VENTILATORSSK952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSK952018PRIMA COAXIAL CIRCUITSK952012PRIMA CUSTOM ANESTESIA CIRCUIT

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Related Devices (Code: BTR)

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.

K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.K253437Spiro-VISTASpiro RoboticsK250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)Covidien, LLCK243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless ReinforcedCovidien, LLCK243579AeroJet Ventilation CatheterPipeline Medical Products, LLCK251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)William Cook Europe Aps

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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