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)

BIOREM 3000 & 4000

K-Number: K833454 · 1984-02-21

ApplicantBiorem
Decision Date1984-02-21
Product CodeLIL
DecisionSubstantially Equivalent

Device Summary

BIOREM 3000 & 4000 is the device name listed in this FDA 510(k) record. The listed applicant is Biorem. It received FDA 510(k) clearance on 1984-02-21 under 510(k) number K833454. The device is classified under product code LIL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOREM 3000 & 4000?

BIOREM 3000 & 4000 is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is Biorem. The 510(k) number is K833454.

When did BIOREM 3000 & 4000 receive FDA 510(k) clearance?

BIOREM 3000 & 4000 received FDA 510(k) clearance on 1984-02-21, under 510(k) number K833454.

Who is the listed applicant for BIOREM 3000 & 4000?

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

What is the FDA product code for BIOREM 3000 & 4000?

The FDA product code for BIOREM 3000 & 4000 is LIL.

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 Biorem 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.

K822099BIOREM 2000

Related Devices (Code: LIL)

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.

K061676RIGIDOMETER, MODEL DIR-4UUroan 21K062042PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)Plethora SolutionsK052929PREFTEST PROFESSIONAL SUITELimestone Technologies, Inc.K033126MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEMBehavioral Technology, Inc.K000194DIGITAL INFLECTION RIGIDOMETER (DIR)Uroan Xxi ElectromedicinaK991479VISER PENILE TUMESCENCE MONITORLaborie Medical Tech 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.

↑