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FDA 510(k)

MODEL LP6 VENTILATOR, MODIFICATION

K-Number: K905244 · 1990-11-30

ApplicantAequitron Medical, Inc.
Decision Date1990-11-30
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL LP6 VENTILATOR, MODIFICATION 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 1990-11-30 under 510(k) number K905244. 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 MODEL LP6 VENTILATOR, MODIFICATION?

MODEL LP6 VENTILATOR, MODIFICATION is a medical device that received FDA 510(k) clearance on 1990-11-30. The listed applicant is Aequitron Medical, Inc.. The 510(k) number is K905244.

When did MODEL LP6 VENTILATOR, MODIFICATION receive FDA 510(k) clearance?

MODEL LP6 VENTILATOR, MODIFICATION received FDA 510(k) clearance on 1990-11-30, under 510(k) number K905244.

Who is the listed applicant for MODEL LP6 VENTILATOR, MODIFICATION?

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 LP6 VENTILATOR, MODIFICATION?

The FDA product code for MODEL LP6 VENTILATOR, MODIFICATION is CBK.

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Other records listing Aequitron Medical, 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.

K961972MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITORK952880MODEL LP-1000 VOLUME VENTILATORK944654OXYGEN CONCENTRATION INDICATORK914424MODEL 6213 REMOTE ALARMK915381PORTABLE OXYGEN GENERATORK911399NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)

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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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