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)

ENRAF-NONIUS SONOPULS 190 SYSTEM

K-Number: K000084 · 2000-08-04

ApplicantHenley Healthcare, Inc.
Decision Date2000-08-04
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ENRAF-NONIUS SONOPULS 190 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Henley Healthcare, Inc.. It received FDA 510(k) clearance on 2000-08-04 under 510(k) number K000084. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENRAF-NONIUS SONOPULS 190 SYSTEM?

ENRAF-NONIUS SONOPULS 190 SYSTEM is a medical device that received FDA 510(k) clearance on 2000-08-04. The listed applicant is Henley Healthcare, Inc.. The 510(k) number is K000084.

When did ENRAF-NONIUS SONOPULS 190 SYSTEM receive FDA 510(k) clearance?

ENRAF-NONIUS SONOPULS 190 SYSTEM received FDA 510(k) clearance on 2000-08-04, under 510(k) number K000084.

Who is the listed applicant for ENRAF-NONIUS SONOPULS 190 SYSTEM?

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

What is the FDA product code for ENRAF-NONIUS SONOPULS 190 SYSTEM?

The FDA product code for ENRAF-NONIUS SONOPULS 190 SYSTEM is IMI.

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 Henley Healthcare, 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.

K003744ENRAF-NONIUS ENDOMED 182 SYSTEM

Related Devices (Code: IMI)

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.

K240788Ultrasound StimulatorJkh Health Co., Ltd.K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K210284ManaSportManamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E OrtoK160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd.

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.

↑