Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

V200 INTELLI-TRAK OPTION

K-Number: K110795 · 2011-08-19

ApplicantRespironics California, Inc.
Decision Date2011-08-19
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

V200 INTELLI-TRAK OPTION 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 2011-08-19 under 510(k) number K110795. 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 V200 INTELLI-TRAK OPTION?

V200 INTELLI-TRAK OPTION is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is Respironics California, Inc.. The 510(k) number is K110795.

When did V200 INTELLI-TRAK OPTION receive FDA 510(k) clearance?

V200 INTELLI-TRAK OPTION received FDA 510(k) clearance on 2011-08-19, under 510(k) number K110795.

Who is the listed applicant for V200 INTELLI-TRAK OPTION?

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 V200 INTELLI-TRAK OPTION?

The FDA product code for V200 INTELLI-TRAK OPTION 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 MODEK102054V200 VENTILATORK082660V60 VENTILATOR, MODEL V8000K072450ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000K071212ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000K051262ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000

View all 11 devices →

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.

↑