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FDA 510(k)

BIOREM 2000

K-Number: K822099 · 1982-08-27

ApplicantBiorem
Decision Date1982-08-27
Product CodeLIL
DecisionSubstantially Equivalent

Device Summary

BIOREM 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Biorem. It received FDA 510(k) clearance on 1982-08-27 under 510(k) number K822099. The device is classified under product code LIL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOREM 2000?

BIOREM 2000 is a medical device that received FDA 510(k) clearance on 1982-08-27. The listed applicant is Biorem. The 510(k) number is K822099.

When did BIOREM 2000 receive FDA 510(k) clearance?

BIOREM 2000 received FDA 510(k) clearance on 1982-08-27, under 510(k) number K822099.

Who is the listed applicant for BIOREM 2000?

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 2000?

The FDA product code for BIOREM 2000 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.

K833454BIOREM 3000 & 4000

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

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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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