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FDA 510(k)

MODEL LP-1000 VOLUME VENTILATOR

K-Number: K952880 · 1996-06-20

ApplicantAequitron Medical, Inc.
Decision Date1996-06-20
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

MODEL LP-1000 VOLUME VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Aequitron Medical, Inc.. It received FDA 510(k) clearance on 1996-06-20 under 510(k) number K952880. 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 MODEL LP-1000 VOLUME VENTILATOR?

MODEL LP-1000 VOLUME VENTILATOR is a medical device that received FDA 510(k) clearance on 1996-06-20. The listed applicant is Aequitron Medical, Inc.. The 510(k) number is K952880.

When did MODEL LP-1000 VOLUME VENTILATOR receive FDA 510(k) clearance?

MODEL LP-1000 VOLUME VENTILATOR received FDA 510(k) clearance on 1996-06-20, under 510(k) number K952880.

Who is the listed applicant for MODEL LP-1000 VOLUME VENTILATOR?

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

What is the FDA product code for MODEL LP-1000 VOLUME VENTILATOR?

The FDA product code for MODEL LP-1000 VOLUME VENTILATOR is CBK.

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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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