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FDA 510(k)

PLM SENSOR, MODEL PLM1

K-Number: K940014 · 1994-11-10

ApplicantPro-Tech, Inc.
Decision Date1994-11-10
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

PLM SENSOR, MODEL PLM1 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 1994-11-10 under 510(k) number K940014. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the PLM SENSOR, MODEL PLM1?

PLM SENSOR, MODEL PLM1 is a medical device that received FDA 510(k) clearance on 1994-11-10. The listed applicant is Pro-Tech, Inc.. The 510(k) number is K940014.

When did PLM SENSOR, MODEL PLM1 receive FDA 510(k) clearance?

PLM SENSOR, MODEL PLM1 received FDA 510(k) clearance on 1994-11-10, under 510(k) number K940014.

Who is the listed applicant for PLM SENSOR, MODEL PLM1?

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 PLM SENSOR, MODEL PLM1?

The FDA product code for PLM SENSOR, MODEL PLM1 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, SM1K924752FREEDOM OXIMETER/EEG DIGITAL INTERFACEK923402CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSORK913396CANNULA STYLE THERMOCOUPLESK913395EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS

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Related Devices (Code: BZQ)

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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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