FDA 510(k)

VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000

K-Number: K002881 · 2000-10-11

Decision Date2000-10-11

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonetic Systems, Inc.. It received FDA 510(k) clearance on 2000-10-11 under 510(k) number K002881. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000?

VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 is a medical device that received FDA 510(k) clearance on 2000-10-11. The listed applicant is Pulmonetic Systems, Inc.. The 510(k) number is K002881.

When did VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 receive FDA 510(k) clearance?

VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 received FDA 510(k) clearance on 2000-10-11, under 510(k) number K002881.

Who is the listed applicant for VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000?

The FDA 510(k) record lists Pulmonetic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000?

The FDA product code for VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 is CBK.

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Other records listing Pulmonetic Systems, Inc. as applicant

K083688PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR K070594PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 K060647LTV 1200 VENTILATOR K060549AUTOMOBILE LIGHTER POWER CORD K051767LTV 1000 VENTILATOR K040790MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS

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Related Devices (Code: CBK)

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa K252663Inbentus VersatileIconic Solutions by Murcia, SL K251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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.