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FDA 510(k)

RESPIRATORY AIRWAY TUBE MONITOR (RATM)

K-Number: K883158 · 1989-03-06

ApplicantVascucare, Inc.
Decision Date1989-03-06
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY AIRWAY TUBE MONITOR (RATM) is the device name listed in this FDA 510(k) record. The listed applicant is Vascucare, Inc.. It received FDA 510(k) clearance on 1989-03-06 under 510(k) number K883158. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRATORY AIRWAY TUBE MONITOR (RATM)?

RESPIRATORY AIRWAY TUBE MONITOR (RATM) is a medical device that received FDA 510(k) clearance on 1989-03-06. The listed applicant is Vascucare, Inc.. The 510(k) number is K883158.

When did RESPIRATORY AIRWAY TUBE MONITOR (RATM) receive FDA 510(k) clearance?

RESPIRATORY AIRWAY TUBE MONITOR (RATM) received FDA 510(k) clearance on 1989-03-06, under 510(k) number K883158.

Who is the listed applicant for RESPIRATORY AIRWAY TUBE MONITOR (RATM)?

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

What is the FDA product code for RESPIRATORY AIRWAY TUBE MONITOR (RATM)?

The FDA product code for RESPIRATORY AIRWAY TUBE MONITOR (RATM) is BZQ.

Related Clinical Trials

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Other records listing Vascucare, 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.

K890047VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEMK881780VASCUCARE ANGIOPUMP

Related Devices (Code: BZQ)

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.

K253274BedDot (G1)Intelligent Dots, LLCK251326Respiration Rate algorithmEdwards Lifesciences, LLCK250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLCK243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.

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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