Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RESPISOMNOGRAPH

K-Number: K861326 · 1986-06-13

ApplicantDickstein, Shapiro & Morin
Decision Date1986-06-13
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPISOMNOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Dickstein, Shapiro & Morin. It received FDA 510(k) clearance on 1986-06-13 under 510(k) number K861326. 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 RESPISOMNOGRAPH?

RESPISOMNOGRAPH is a medical device that received FDA 510(k) clearance on 1986-06-13. The listed applicant is Dickstein, Shapiro & Morin. The 510(k) number is K861326.

When did RESPISOMNOGRAPH receive FDA 510(k) clearance?

RESPISOMNOGRAPH received FDA 510(k) clearance on 1986-06-13, under 510(k) number K861326.

Who is the listed applicant for RESPISOMNOGRAPH?

The FDA 510(k) record lists Dickstein, Shapiro & Morin as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPISOMNOGRAPH?

The FDA product code for RESPISOMNOGRAPH 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dickstein, Shapiro & Morin 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.

K863538RESPICENTRAL(TM)

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.

↑