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)

QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER

K-Number: K911369 · 1991-05-13

ApplicantDeroyal Industries, Inc.
Decision Date1991-05-13
Product CodeMDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1991-05-13 under 510(k) number K911369. The device is classified under product code MDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER?

QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER is a medical device that received FDA 510(k) clearance on 1991-05-13. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K911369.

When did QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER receive FDA 510(k) clearance?

QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER received FDA 510(k) clearance on 1991-05-13, under 510(k) number K911369.

Who is the listed applicant for QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER?

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

What is the FDA product code for QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER?

The FDA product code for QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER is MDM.

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 Deroyal Industries, 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.

K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam AccessoryK230233Prospera Spectruum Negative Pressure Wound Therapy SystemK200631DeRoyal Temperature Monitoring ProbeK200757Foley Catheter with Temperature SensorK200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableK193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French

View all 90 devices →

Related Devices (Code: MDM)

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.

K073664FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCERInjectimed, Inc.K050575FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEMFutumeds Sdn BhdK050957EUTROCHARSpecial Devices, Inc.K023173ANDREWS INTRODUCER, MODEL ASI01Andrews Surgical Innovations, Ltd.K022059MICROVASIVE PULMONARY GUIDEWIREBoston Scientific CorpK013040LIGHT SABER INTRODUCER NEEDLEMinrad, Inc.

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.

↑