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)

WELCH ALLYN HI - LUX ILLUMINATOR

K-Number: K951647 · 1995-05-17

ApplicantWelch Allyn, Inc.
Decision Date1995-05-17
Product CodeFCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WELCH ALLYN HI - LUX ILLUMINATOR is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 1995-05-17 under 510(k) number K951647. The device is classified under product code FCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELCH ALLYN HI - LUX ILLUMINATOR?

WELCH ALLYN HI - LUX ILLUMINATOR is a medical device that received FDA 510(k) clearance on 1995-05-17. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K951647.

When did WELCH ALLYN HI - LUX ILLUMINATOR receive FDA 510(k) clearance?

WELCH ALLYN HI - LUX ILLUMINATOR received FDA 510(k) clearance on 1995-05-17, under 510(k) number K951647.

Who is the listed applicant for WELCH ALLYN HI - LUX ILLUMINATOR?

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

What is the FDA product code for WELCH ALLYN HI - LUX ILLUMINATOR?

The FDA product code for WELCH ALLYN HI - LUX ILLUMINATOR is FCW.

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 Welch Allyn, 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.

K243598Welch Allyn Connex® 360 (Multiple)K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)K223381iExaminer System with Panoptic PlusK212473Welch Allyn Connex Central StationK191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionK181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

View all 109 devices →

Related Devices (Code: FCW)

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.

K123956POWER LED 175KARL STORZ Endoscopy-America, Inc.K123359OVS1 VIDEO SYSTEMOlive Medical Corp.K121724ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2Richard Wolf Medical Instruments Corp.K093792LED LIGHT SOURCESunoptic Technologies, LLCK091968KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020CKARL STORZ Endoscopy-America, Inc.K082813STRYKER LED LIGHTSOURCEStryker 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.

↑