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FDA 510(k)

SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E

K-Number: K010925 · 2001-12-18

ApplicantSiemens Elema AB
Decision Date2001-12-18
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Elema AB. It received FDA 510(k) clearance on 2001-12-18 under 510(k) number K010925. 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 SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E?

SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E is a medical device that received FDA 510(k) clearance on 2001-12-18. The listed applicant is Siemens Elema AB. The 510(k) number is K010925.

When did SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E receive FDA 510(k) clearance?

SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E received FDA 510(k) clearance on 2001-12-18, under 510(k) number K010925.

Who is the listed applicant for SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E?

The FDA 510(k) record lists Siemens Elema AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E?

The FDA product code for SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E is CBK.

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Other records listing Siemens Elema AB 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.

K023354COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81EK010923KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392EK002137CATHCOR DESKTOPK001315MODIFICATION TO KION ANESTHESIA SYSTEMK970839SERVO VENTILATOR 300AK960010SERVO VENTILATOR 300 COMPUTER INTERFACE

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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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