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510(k) Data Aggregation

K Number

K111595

Device Name

NEUMOVENT GRAPHNET

Manufacturer

TECME S.A.

Date Cleared

2012-01-27

(234 days)

Product Code

CBK

Regulation Number

868.5895

Intended Use

Model: Advance Intended to provide continuous ventilation to patients requiring respiratory support. The devices are intended for patients from neonate/infant to adult. The devices are intended to be used in hospital and hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied. Model: Neumovent GraphNet TS Intended to provide continuous ventilation to patients respiratory support. The devices are intended for patients from pediatric to adult with an option for neonate/infant patients. The devices are intended to be used in hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied. Model: Neumovent GraphNet NEO Intended to provide continuous ventilation to patients requiring respiratory support. The devices are intended for neonate/infant patient. The devices are intended to be used in hospital and hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.

Device Description

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K Number

K101401