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FDA 510(k)

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM

K-Number: K160540 · 2016-06-23

ApplicantFlexicare Medical Limited.
Decision Date2016-06-23
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM is a medical device manufactured by Flexicare Medical Limited.. It received FDA 510(k) clearance on 2016-06-23 under approval number K160540. 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 FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM?

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM is a medical device that received FDA 510(k) clearance on 2016-06-23. It is manufactured by Flexicare Medical Limited.. The 510(k) number is K160540.

When was FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM approved by the FDA?

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM received FDA 510(k) clearance on 2016-06-23, under approval number K160540.

What company makes FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM?

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM is manufactured by Flexicare Medical Limited..

What is the FDA product code for FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM?

The FDA product code for FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM is BZE.

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Other Devices by Flexicare Medical Limited.

K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE K163300ThermoShield HME Filter K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 K201666SINGLE USE MANOMETER K191909HepaShield Bacterial Viral Breathing System Filter K250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)

View all 8 devices →

Related Devices (Code: BZE)

K153234AirLife Adult Heated Wire CircuitCarefusion, Inc. K151461Hybernite RTPlastiflex Group NV K151303AirLife Infant Heated Wire CircuitCare Fusion K151959AirLife Infant Single Limb Heated Wire CircuitCarefusion, Inc. K170378AirLife Adult Heated Wire BiPAP/NIV CircuitVyaire Medical K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, 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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