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FDA 510(k)

RAPHAEL COLOR ASV VENTILATOR

K-Number: K071194 · 2007-10-18

ApplicantHamilton Medical AG
Decision Date2007-10-18
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RAPHAEL COLOR ASV VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Medical AG. It received FDA 510(k) clearance on 2007-10-18 under 510(k) number K071194. 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 RAPHAEL COLOR ASV VENTILATOR?

RAPHAEL COLOR ASV VENTILATOR is a medical device that received FDA 510(k) clearance on 2007-10-18. The listed applicant is Hamilton Medical AG. The 510(k) number is K071194.

When did RAPHAEL COLOR ASV VENTILATOR receive FDA 510(k) clearance?

RAPHAEL COLOR ASV VENTILATOR received FDA 510(k) clearance on 2007-10-18, under 510(k) number K071194.

Who is the listed applicant for RAPHAEL COLOR ASV VENTILATOR?

The FDA 510(k) record lists Hamilton Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPHAEL COLOR ASV VENTILATOR?

The FDA product code for RAPHAEL COLOR ASV VENTILATOR is CBK.

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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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hamilton Medical AG 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.

K201306HAMILTON-C3K201658Hamilton-C6K193228Hamilton-G5K181216HAMILTON-T1, HAMILTON-C1K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010K161450HAMILTON-C3

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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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