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FDA 510(k)

ECG/RESPIRATION STIMULATOR

K-Number: K802205 · 1980-10-03

ApplicantHealthdyne, Inc.
Decision Date1980-10-03
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ECG/RESPIRATION STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1980-10-03 under 510(k) number K802205. 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 ECG/RESPIRATION STIMULATOR?

ECG/RESPIRATION STIMULATOR is a medical device that received FDA 510(k) clearance on 1980-10-03. The listed applicant is Healthdyne, Inc.. The 510(k) number is K802205.

When did ECG/RESPIRATION STIMULATOR receive FDA 510(k) clearance?

ECG/RESPIRATION STIMULATOR received FDA 510(k) clearance on 1980-10-03, under 510(k) number K802205.

Who is the listed applicant for ECG/RESPIRATION STIMULATOR?

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

What is the FDA product code for ECG/RESPIRATION STIMULATOR?

The FDA product code for ECG/RESPIRATION STIMULATOR is BZQ.

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Other records listing Healthdyne, 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.

K950331PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)K922106ALICEK942357H-500 ALLIANCE OXYGEN CONCENTRATORK934502FLOW SPIROMETERK924146OH-500 OXYGEN CONCENTRATORK922623NEBULIZER SYSTEM

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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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