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FDA 510(k)

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM

K-Number: K160540 · 2016-06-23

Decision Date2016-06-23
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Flexicare Medical Limited.. It received FDA 510(k) clearance on 2016-06-23 under 510(k) 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. The listed applicant is Flexicare Medical Limited.. The 510(k) number is K160540.

When did FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM receive FDA 510(k) clearance?

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

Who is the listed applicant for FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM?

The FDA 510(k) record lists Flexicare Medical Limited. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Flexicare Medical Limited. 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.

View all 8 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.

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.