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FDA 510(k)

AVEA disposable expiratory filter/water trap (11790)

K-Number: K251133 · 2025-05-08

ApplicantTelesair, Inc.
Decision Date2025-05-08
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AVEA disposable expiratory filter/water trap (11790) is the device name listed in this FDA 510(k) record. The listed applicant is Telesair, Inc.. It received FDA 510(k) clearance on 2025-05-08 under 510(k) number K251133. 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 AVEA disposable expiratory filter/water trap (11790)?

AVEA disposable expiratory filter/water trap (11790) is a medical device that received FDA 510(k) clearance on 2025-05-08. The listed applicant is Telesair, Inc.. The 510(k) number is K251133.

When did AVEA disposable expiratory filter/water trap (11790) receive FDA 510(k) clearance?

AVEA disposable expiratory filter/water trap (11790) received FDA 510(k) clearance on 2025-05-08, under 510(k) number K251133.

Who is the listed applicant for AVEA disposable expiratory filter/water trap (11790)?

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

What is the FDA product code for AVEA disposable expiratory filter/water trap (11790)?

The FDA product code for AVEA disposable expiratory filter/water trap (11790) is CBK.

Other records listing Telesair, 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.

K223863BONHAWA Respiratory Humidifier

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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