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FDA 510(k)

ARF 850 E

K-Number: K831877 · 1983-11-03

ApplicantW.E. Leder Enterprises, Inc.
Decision Date1983-11-03
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ARF 850 E is the device name listed in this FDA 510(k) record. The listed applicant is W.E. Leder Enterprises, Inc.. It received FDA 510(k) clearance on 1983-11-03 under 510(k) number K831877. 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 ARF 850 E?

ARF 850 E is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is W.E. Leder Enterprises, Inc.. The 510(k) number is K831877.

When did ARF 850 E receive FDA 510(k) clearance?

ARF 850 E received FDA 510(k) clearance on 1983-11-03, under 510(k) number K831877.

Who is the listed applicant for ARF 850 E?

The FDA 510(k) record lists W.E. Leder Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARF 850 E?

The FDA product code for ARF 850 E is CBK.

Other records listing W.E. Leder Enterprises, 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.

K831981LARYNGESCOPEK831878CARDIO-SCOPE MINI MONITORK830161ANESTHESIA APATATUS #D-25K830160ANESTHESIA APPARATUS #FO 20SK830159ANESTHESIA APPARATUS PH-35

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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