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FDA 510(k)

CARINA HOME

K-Number: K060705 · 2006-06-14

ApplicantDraeger Medical B.V.
Decision Date2006-06-14
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CARINA HOME is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical B.V.. It received FDA 510(k) clearance on 2006-06-14 under 510(k) number K060705. 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 CARINA HOME?

CARINA HOME is a medical device that received FDA 510(k) clearance on 2006-06-14. The listed applicant is Draeger Medical B.V.. The 510(k) number is K060705.

When did CARINA HOME receive FDA 510(k) clearance?

CARINA HOME received FDA 510(k) clearance on 2006-06-14, under 510(k) number K060705.

Who is the listed applicant for CARINA HOME?

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

What is the FDA product code for CARINA HOME?

The FDA product code for CARINA HOME 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.

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Other records listing Draeger Medical B.V. 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.

K082600OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)

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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