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FDA 510(k)

ESOPHAGEAL INTUBATION DETECTOR

K-Number: K962098 · 1996-10-08

ApplicantKirk Specialty Systems
Decision Date1996-10-08
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL INTUBATION DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Kirk Specialty Systems. It received FDA 510(k) clearance on 1996-10-08 under 510(k) number K962098. 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 ESOPHAGEAL INTUBATION DETECTOR?

ESOPHAGEAL INTUBATION DETECTOR is a medical device that received FDA 510(k) clearance on 1996-10-08. The listed applicant is Kirk Specialty Systems. The 510(k) number is K962098.

When did ESOPHAGEAL INTUBATION DETECTOR receive FDA 510(k) clearance?

ESOPHAGEAL INTUBATION DETECTOR received FDA 510(k) clearance on 1996-10-08, under 510(k) number K962098.

Who is the listed applicant for ESOPHAGEAL INTUBATION DETECTOR?

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

What is the FDA product code for ESOPHAGEAL INTUBATION DETECTOR?

The FDA product code for ESOPHAGEAL INTUBATION DETECTOR is BTR.

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 Kirk Specialty Systems 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.

K952512CAPNO-FLO REGULATOR, CAPNO-FLOK945822CAPNO-FLO(TM) REGULATORK933626CAPNO-FLO

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

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