FDA 510(k)

PENLON TRANSPORT VENTILATOR SERIES 350

K-Number: K842362 · 1984-06-26

Decision Date1984-06-26

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

PENLON TRANSPORT VENTILATOR SERIES 350 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 K842362. 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 TRANSPORT VENTILATOR SERIES 350?

PENLON TRANSPORT VENTILATOR SERIES 350 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 K842362.

When did PENLON TRANSPORT VENTILATOR SERIES 350 receive FDA 510(k) clearance?

PENLON TRANSPORT VENTILATOR SERIES 350 received FDA 510(k) clearance on 1984-06-26, under 510(k) number K842362.

Who is the listed applicant for PENLON TRANSPORT VENTILATOR SERIES 350?

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 TRANSPORT VENTILATOR SERIES 350?

The FDA product code for PENLON TRANSPORT VENTILATOR SERIES 350 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 28 devices →

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.