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FDA 510(k)

ALARM UNIT, BATTERY OPERATED

K-Number: K781158 · 1978-12-18

ApplicantThompson Respiration Products, Inc.
Decision Date1978-12-18
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ALARM UNIT, BATTERY OPERATED is the device name listed in this FDA 510(k) record. The listed applicant is Thompson Respiration Products, Inc.. It received FDA 510(k) clearance on 1978-12-18 under 510(k) number K781158. 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 ALARM UNIT, BATTERY OPERATED?

ALARM UNIT, BATTERY OPERATED is a medical device that received FDA 510(k) clearance on 1978-12-18. The listed applicant is Thompson Respiration Products, Inc.. The 510(k) number is K781158.

When did ALARM UNIT, BATTERY OPERATED receive FDA 510(k) clearance?

ALARM UNIT, BATTERY OPERATED received FDA 510(k) clearance on 1978-12-18, under 510(k) number K781158.

Who is the listed applicant for ALARM UNIT, BATTERY OPERATED?

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

What is the FDA product code for ALARM UNIT, BATTERY OPERATED?

The FDA product code for ALARM UNIT, BATTERY OPERATED is BZQ.

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Other records listing Thompson Respiration Products, 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.

K822103MODEL M3000XA VENTILATOR SPECIFICAK782174PRESSURE ALARMK781160VENTILATOR, MINILUNGK781159VENTILATOR, PRESSUREK781161RESPIRATOR, BANTAM MODEL

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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