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FDA 510(k)

ELECTROSTATIC HYDROPHOBIC BREATHING FILTER

K-Number: K002201 · 2001-02-05

ApplicantSims Portex, Inc.
Decision Date2001-02-05
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ELECTROSTATIC HYDROPHOBIC BREATHING FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Sims Portex, Inc.. It received FDA 510(k) clearance on 2001-02-05 under 510(k) number K002201. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROSTATIC HYDROPHOBIC BREATHING FILTER?

ELECTROSTATIC HYDROPHOBIC BREATHING FILTER is a medical device that received FDA 510(k) clearance on 2001-02-05. The listed applicant is Sims Portex, Inc.. The 510(k) number is K002201.

When did ELECTROSTATIC HYDROPHOBIC BREATHING FILTER receive FDA 510(k) clearance?

ELECTROSTATIC HYDROPHOBIC BREATHING FILTER received FDA 510(k) clearance on 2001-02-05, under 510(k) number K002201.

Who is the listed applicant for ELECTROSTATIC HYDROPHOBIC BREATHING FILTER?

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

What is the FDA product code for ELECTROSTATIC HYDROPHOBIC BREATHING FILTER?

The FDA product code for ELECTROSTATIC HYDROPHOBIC BREATHING FILTER is CAH.

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Other records listing Sims Portex, 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.

K011925HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIOK002506BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUITK001318CPAP SYSTEM, MODEL 102001K993619CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCKK994275SIMS PORTEX ANESTHESIA CATHETERK9918611ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE

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Related Devices (Code: CAH)

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.

K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd.K251583Ambu® Virobac II® Exhalation FilterAmbu A/SK241339Besmed Bacterial Filter and HMEFBesmed Health Business CorpK222917Breathing circuit bacterial/viral filterShaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)Intersurgical , 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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