FDA 510(k)

OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072

K-Number: K023289 · 2003-01-15

Decision Date2003-01-15

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 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 2003-01-15 under 510(k) number K023289. 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 OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072?

OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 is a medical device that received FDA 510(k) clearance on 2003-01-15. The listed applicant is Drager Medizintechnik GmbH. The 510(k) number is K023289.

When did OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 receive FDA 510(k) clearance?

OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 received FDA 510(k) clearance on 2003-01-15, under 510(k) number K023289.

Who is the listed applicant for OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072?

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 OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072?

The FDA product code for OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Drager Medizintechnik GmbH as applicant

K010793OXYLOG 1000, MODEL 2M86840 K012177VENTVIEW, MODEL 8414095 K003068SAVINA K010093NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 K010724SOLA 700,SOLA 500, SOLA 300 K003067CALEO

View all 8 devices →

Related Devices (Code: CBK)

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa K252663Inbentus VersatileIconic Solutions by Murcia, SL K251888VPAP 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.