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FDA 510(k)

KING SYSTEMS HME

K-Number: K934441 · 1993-12-02

ApplicantKing Systems Corp.
Decision Date1993-12-02
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

KING SYSTEMS HME is the device name listed in this FDA 510(k) record. The listed applicant is King Systems Corp.. It received FDA 510(k) clearance on 1993-12-02 under 510(k) number K934441. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KING SYSTEMS HME?

KING SYSTEMS HME is a medical device that received FDA 510(k) clearance on 1993-12-02. The listed applicant is King Systems Corp.. The 510(k) number is K934441.

When did KING SYSTEMS HME receive FDA 510(k) clearance?

KING SYSTEMS HME received FDA 510(k) clearance on 1993-12-02, under 510(k) number K934441.

Who is the listed applicant for KING SYSTEMS HME?

The FDA 510(k) record lists King Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KING SYSTEMS HME?

The FDA product code for KING SYSTEMS HME is BYD.

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 King Systems Corp. 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.

K033189KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305K033186KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205K021634KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105K012485MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCEK010040SLEEVED FILTERK990614HME-BOOSTER

View all 18 devices →

Related Devices (Code: BYD)

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.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, 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.

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