FDA 510(k)

RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD

K-Number: K062019 · 2006-08-17

ApplicantInnomed Technologies, Inc./Respcare, Inc.

Decision Date2006-08-17

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD is the device name listed in this FDA 510(k) record. The listed applicant is Innomed Technologies, Inc./Respcare, Inc.. It received FDA 510(k) clearance on 2006-08-17 under 510(k) number K062019. 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 RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD?

RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD is a medical device that received FDA 510(k) clearance on 2006-08-17. The listed applicant is Innomed Technologies, Inc./Respcare, Inc.. The 510(k) number is K062019.

When did RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD receive FDA 510(k) clearance?

RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD received FDA 510(k) clearance on 2006-08-17, under 510(k) number K062019.

Who is the listed applicant for RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD?

The FDA 510(k) record lists Innomed Technologies, Inc./Respcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD?

The FDA product code for RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD 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 Innomed Technologies, Inc./Respcare, Inc. as applicant

K090804NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD

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.