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FDA 510(k)

MODIFICATION TO LAP TOP VENTILATOR (LTV)

K-Number: K010608 · 2001-03-20

ApplicantPulmonetic Systems, Inc.
Decision Date2001-03-20
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LAP TOP VENTILATOR (LTV) 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 2001-03-20 under 510(k) number K010608. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO LAP TOP VENTILATOR (LTV)?

MODIFICATION TO LAP TOP VENTILATOR (LTV) is a medical device that received FDA 510(k) clearance on 2001-03-20. The listed applicant is Pulmonetic Systems, Inc.. The 510(k) number is K010608.

When did MODIFICATION TO LAP TOP VENTILATOR (LTV) receive FDA 510(k) clearance?

MODIFICATION TO LAP TOP VENTILATOR (LTV) received FDA 510(k) clearance on 2001-03-20, under 510(k) number K010608.

Who is the listed applicant for MODIFICATION TO LAP TOP VENTILATOR (LTV)?

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 MODIFICATION TO LAP TOP VENTILATOR (LTV)?

The FDA product code for MODIFICATION TO LAP TOP VENTILATOR (LTV) is CBK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pulmonetic Systems, Inc. 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.

K083688PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATORK070594PALMTOP VENTILATOR, MODELS PTV-8, PTV-10K060647LTV 1200 VENTILATORK060549AUTOMOBILE LIGHTER POWER CORDK051767LTV 1000 VENTILATORK040790MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS

View all 12 devices →

Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP 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.

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