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FDA 510(k)

HYBERNITE RAINOUT CONTROL SYSTEM

K-Number: K100104 · 2010-04-14

ApplicantPlastiflex Group NV
Decision Date2010-04-14
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HYBERNITE RAINOUT CONTROL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Plastiflex Group NV. It received FDA 510(k) clearance on 2010-04-14 under 510(k) number K100104. 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 HYBERNITE RAINOUT CONTROL SYSTEM?

HYBERNITE RAINOUT CONTROL SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-14. The listed applicant is Plastiflex Group NV. The 510(k) number is K100104.

When did HYBERNITE RAINOUT CONTROL SYSTEM receive FDA 510(k) clearance?

HYBERNITE RAINOUT CONTROL SYSTEM received FDA 510(k) clearance on 2010-04-14, under 510(k) number K100104.

Who is the listed applicant for HYBERNITE RAINOUT CONTROL SYSTEM?

The FDA 510(k) record lists Plastiflex Group NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYBERNITE RAINOUT CONTROL SYSTEM?

The FDA product code for HYBERNITE RAINOUT CONTROL SYSTEM is BZE.

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.

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Other records listing Plastiflex Group NV 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.

K151461Hybernite RT

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

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