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)

MODEL 2000W OPTION H CONFIGURATION

K-Number: K871302 · 1987-04-20

ApplicantEdentec Corp.
Decision Date1987-04-20
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 2000W OPTION H CONFIGURATION is the device name listed in this FDA 510(k) record. The listed applicant is Edentec Corp.. It received FDA 510(k) clearance on 1987-04-20 under 510(k) number K871302. 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 MODEL 2000W OPTION H CONFIGURATION?

MODEL 2000W OPTION H CONFIGURATION is a medical device that received FDA 510(k) clearance on 1987-04-20. The listed applicant is Edentec Corp.. The 510(k) number is K871302.

When did MODEL 2000W OPTION H CONFIGURATION receive FDA 510(k) clearance?

MODEL 2000W OPTION H CONFIGURATION received FDA 510(k) clearance on 1987-04-20, under 510(k) number K871302.

Who is the listed applicant for MODEL 2000W OPTION H CONFIGURATION?

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

What is the FDA product code for MODEL 2000W OPTION H CONFIGURATION?

The FDA product code for MODEL 2000W OPTION H CONFIGURATION 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 Edentec Corp. 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.

K953363OXIFLOW DIGITAL RECORDERK953540EEEK921819EDENTEC MODEL 3710 I DIGITAL PRINTERK913749EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170K910870EDENTEC MODEL 3711 DIGITAL RECORDERK910871EDENTEC DIGITAL CHARTER MODEL 3710

View all 18 devices →

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.

↑