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FDA 510(k)

ARM-A-VIAL LV HEATER-BREATHING SYS

K-Number: K844005 · 1984-11-08

ApplicantArmour Pharmaceutical Co.
Decision Date1984-11-08
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ARM-A-VIAL LV HEATER-BREATHING SYS is the device name listed in this FDA 510(k) record. The listed applicant is Armour Pharmaceutical Co.. It received FDA 510(k) clearance on 1984-11-08 under 510(k) number K844005. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARM-A-VIAL LV HEATER-BREATHING SYS?

ARM-A-VIAL LV HEATER-BREATHING SYS is a medical device that received FDA 510(k) clearance on 1984-11-08. The listed applicant is Armour Pharmaceutical Co.. The 510(k) number is K844005.

When did ARM-A-VIAL LV HEATER-BREATHING SYS receive FDA 510(k) clearance?

ARM-A-VIAL LV HEATER-BREATHING SYS received FDA 510(k) clearance on 1984-11-08, under 510(k) number K844005.

Who is the listed applicant for ARM-A-VIAL LV HEATER-BREATHING SYS?

The FDA 510(k) record lists Armour Pharmaceutical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARM-A-VIAL LV HEATER-BREATHING SYS?

The FDA product code for ARM-A-VIAL LV HEATER-BREATHING SYS is BZE.

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Other records listing Armour Pharmaceutical Co. 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.

K842209ARM-A-FLOW INTRAVENOUS FLOW REGULATORK841991ARM-A-CARE HUMIDIFIER-RESPIRATORY GASK841990ARM-A-CARE NEBULIZER-NEBULIZERK841989ARM-A-VIAL LV SODIUM CHLORIDE INHALATK841988ARM-A-VIAL LV SODIUM, CHLORIDE INHALATK841987ARM-A-VIAL LV STERIAL WATER FOR INHALA

View all 7 devices →

Related Devices (Code: BZE)

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.

K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20)Vincent Healthcare Products LimitedK253322Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)Medline Industries, LPK243244Heated Breathing TubeGuangdong Eda Technology Co., Ltd.K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron MedicalK234032Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension LineMedline Industries, LPK222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Draegerwerk AG & CO Kgaa

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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