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FDA 510(k)

VENTVIEW, MODEL 8414095

K-Number: K012177 · 2001-09-04

ApplicantDrager Medizintechnik GmbH
Decision Date2001-09-04
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTVIEW, MODEL 8414095 is the device name listed in this FDA 510(k) record. The listed applicant is Drager Medizintechnik GmbH. It received FDA 510(k) clearance on 2001-09-04 under 510(k) number K012177. 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 VENTVIEW, MODEL 8414095?

VENTVIEW, MODEL 8414095 is a medical device that received FDA 510(k) clearance on 2001-09-04. The listed applicant is Drager Medizintechnik GmbH. The 510(k) number is K012177.

When did VENTVIEW, MODEL 8414095 receive FDA 510(k) clearance?

VENTVIEW, MODEL 8414095 received FDA 510(k) clearance on 2001-09-04, under 510(k) number K012177.

Who is the listed applicant for VENTVIEW, MODEL 8414095?

The FDA 510(k) record lists Drager Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTVIEW, MODEL 8414095?

The FDA product code for VENTVIEW, MODEL 8414095 is CBK.

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Other records listing Drager Medizintechnik GmbH 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.

K023289OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072K010793OXYLOG 1000, MODEL 2M86840K003068SAVINAK010093NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474K010724SOLA 700,SOLA 500, SOLA 300K003067CALEO

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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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