FDA 510(k)

PENLON ANESTHESIA VENTILATOR SERIES 300

K-Number: K842363 · 1984-06-26

Decision Date1984-06-26

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

PENLON ANESTHESIA VENTILATOR SERIES 300 is the device name listed in this FDA 510(k) record. The listed applicant is Bear Medical Systems, Inc.. It received FDA 510(k) clearance on 1984-06-26 under 510(k) number K842363. 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 PENLON ANESTHESIA VENTILATOR SERIES 300?

PENLON ANESTHESIA VENTILATOR SERIES 300 is a medical device that received FDA 510(k) clearance on 1984-06-26. The listed applicant is Bear Medical Systems, Inc.. The 510(k) number is K842363.

When did PENLON ANESTHESIA VENTILATOR SERIES 300 receive FDA 510(k) clearance?

PENLON ANESTHESIA VENTILATOR SERIES 300 received FDA 510(k) clearance on 1984-06-26, under 510(k) number K842363.

Who is the listed applicant for PENLON ANESTHESIA VENTILATOR SERIES 300?

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

What is the FDA product code for PENLON ANESTHESIA VENTILATOR SERIES 300?

The FDA product code for PENLON ANESTHESIA VENTILATOR SERIES 300 is CBK.

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Other records listing Bear Medical Systems, Inc. as applicant

K992788BEAR CUB 750 PSV K983981BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE K912619BEAR 7 VENTILATOR K900637BEAR CEM CONTROLLER K896315BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY K893034VHS 820 HUMIDIFIER, MODIFICATION

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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.