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FDA 510(k)

CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR

K-Number: K923402 · 1992-12-30

ApplicantPro-Tech, Inc.
Decision Date1992-12-30
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Tech, Inc.. It received FDA 510(k) clearance on 1992-12-30 under 510(k) number K923402. 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 CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR?

CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR is a medical device that received FDA 510(k) clearance on 1992-12-30. The listed applicant is Pro-Tech, Inc.. The 510(k) number is K923402.

When did CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR receive FDA 510(k) clearance?

CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR received FDA 510(k) clearance on 1992-12-30, under 510(k) number K923402.

Who is the listed applicant for CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR?

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

What is the FDA product code for CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR?

The FDA product code for CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR is BZQ.

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Other records listing Pro-Tech, 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.

K940013BODY POSITION INDICATOR, MODEL BPI1K940015SNORING MICROPHONE, SM1K940014PLM SENSOR, MODEL PLM1K924752FREEDOM OXIMETER/EEG DIGITAL INTERFACEK913396CANNULA STYLE THERMOCOUPLESK913395EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS

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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

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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