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)

EPILOT 80 S TM

K-Number: K833946 · 1984-04-04

ApplicantLeo Unlimited, Inc.
Decision Date1984-04-04
Product CodeKCW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPILOT 80 S TM is the device name listed in this FDA 510(k) record. The listed applicant is Leo Unlimited, Inc.. It received FDA 510(k) clearance on 1984-04-04 under 510(k) number K833946. The device is classified under product code KCW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPILOT 80 S TM?

EPILOT 80 S TM is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is Leo Unlimited, Inc.. The 510(k) number is K833946.

When did EPILOT 80 S TM receive FDA 510(k) clearance?

EPILOT 80 S TM received FDA 510(k) clearance on 1984-04-04, under 510(k) number K833946.

Who is the listed applicant for EPILOT 80 S TM?

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

What is the FDA product code for EPILOT 80 S TM?

The FDA product code for EPILOT 80 S TM is KCW.

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 Leo Unlimited, 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.

K834572EPITRON SUPERK833945COSMODYN-S INTERFERENTIAL MUSCLE STIM

Related Devices (Code: KCW)

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.

K954031COMPU-BLEND EPILATORR. A. Fischer Co. Corp.K952611STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATIONSterex Electrolysis Intl., Ltd.K945192HAIR REMOVAL SYSTEML.P. Systems Corp.K943928APILUS ELECTROPILDectro Intl., Inc.K943398THE BLENDTONE ROYALEInstantronK943396THE ELITE SPECTRUMInstantron

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.

↑