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FDA 510(k)

AV 800 VENTILATOR

K-Number: K010317 · 2001-07-23

ApplicantPenlon , Ltd.
Decision Date2001-07-23
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AV 800 VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Penlon , Ltd.. It received FDA 510(k) clearance on 2001-07-23 under 510(k) number K010317. 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 AV 800 VENTILATOR?

AV 800 VENTILATOR is a medical device that received FDA 510(k) clearance on 2001-07-23. The listed applicant is Penlon , Ltd.. The 510(k) number is K010317.

When did AV 800 VENTILATOR receive FDA 510(k) clearance?

AV 800 VENTILATOR received FDA 510(k) clearance on 2001-07-23, under 510(k) number K010317.

Who is the listed applicant for AV 800 VENTILATOR?

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

What is the FDA product code for AV 800 VENTILATOR?

The FDA product code for AV 800 VENTILATOR is CBK.

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Other records listing Penlon , Ltd. 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.

K061102PRIMA ANAESTHESIA MACHINEK041076DELTA TK010318PRIMA OXYGEN MONITORK002343SIGMA DELTAK961468QUIK-FIL VAPORIZER KEYED FILLERK960944PPV VAPORIZER (MODIFICATION)

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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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