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FDA 510(k)

ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000

K-Number: K041412 · 2004-06-18

ApplicantRespironics California, Inc.
Decision Date2004-06-18
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics California, Inc.. It received FDA 510(k) clearance on 2004-06-18 under 510(k) number K041412. 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 ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000?

ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 is a medical device that received FDA 510(k) clearance on 2004-06-18. The listed applicant is Respironics California, Inc.. The 510(k) number is K041412.

When did ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 receive FDA 510(k) clearance?

ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 received FDA 510(k) clearance on 2004-06-18, under 510(k) number K041412.

Who is the listed applicant for ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000?

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

What is the FDA product code for ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000?

The FDA product code for ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 is CBK.

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Other records listing Respironics California, 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.

K110083V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODEK110795V200 INTELLI-TRAK OPTIONK102054V200 VENTILATORK082660V60 VENTILATOR, MODEL V8000K072450ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000K071212ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000

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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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