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FDA 510(k)

ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR

K-Number: K852515 · 1985-06-24

ApplicantAlternative Design Systems, Inc.
Decision Date1985-06-24
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Alternative Design Systems, Inc.. It received FDA 510(k) clearance on 1985-06-24 under 510(k) number K852515. 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 ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR?

ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR is a medical device that received FDA 510(k) clearance on 1985-06-24. The listed applicant is Alternative Design Systems, Inc.. The 510(k) number is K852515.

When did ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR receive FDA 510(k) clearance?

ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR received FDA 510(k) clearance on 1985-06-24, under 510(k) number K852515.

Who is the listed applicant for ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR?

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

What is the FDA product code for ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR?

The FDA product code for ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR is BZQ.

Related Clinical Trials

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.

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Other records listing Alternative Design Systems, 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.

K874719STRATUM ESUK874697STRATUM DK8547575000 SERIES ECG ELECTRODESK853633TENS CONDUCTIVE MEDIA PADK830778MONITORING KIT AMK-1

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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