LTV-1000 Ventilator

• • Terminated Z-1485-04 FDA Unclassified (pre-2012) ·initiated 8 Sep 2004

  Ventilators have not consistently switched to internal battery operation when the external DC power source has become inadequate to supply stable power. This situation results in loss of ventilation to the patient.

510(k) Number

K032226 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Ltv 1000 Ventilator

  Class II

  FDA 510(k) K051767 Active Cleared 29 Jul 2005

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  FDA 510(k) K083688 Active Cleared 18 Mar 2009

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• Palmtop Ventilator, Models Ptv-8, Ptv-10

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  Class II

  FDA 510(k) K060647 Active Cleared 25 May 2006

See all devices from Pulmonetic Systems, Inc. →

• What is the LTV-1000 Ventilator used for?

  The LTV-1000 Ventilator is designed for ventilatory support in clinical settings, providing continuous ventilatory assistance to patients requiring respiratory support in facility-based environments.

• How is the LTV-1000 Ventilator supplied and authorized?

  The LTV-1000 Ventilator is supplied by Pulmonetic Systems, Inc. and is authorized under FDA 510(k) clearance K032226, which determined it to be substantially equivalent to a legally marketed device through the traditional 510(k) process.

• Is the LTV-1000 Ventilator described as single-use or reusable?

  The provided device data does not specify whether the LTV-1000 Ventilator is intended for single-use or reuse; no information regarding reusability, sterility, or reprocessing is included in the authorization details.