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FDA 510(k)

STERI-CATH MDI

K-Number: K923559 · 1993-10-25

ApplicantConcord/Portex
Decision Date1993-10-25
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STERI-CATH MDI is the device name listed in this FDA 510(k) record. The listed applicant is Concord/Portex. It received FDA 510(k) clearance on 1993-10-25 under 510(k) number K923559. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERI-CATH MDI?

STERI-CATH MDI is a medical device that received FDA 510(k) clearance on 1993-10-25. The listed applicant is Concord/Portex. The 510(k) number is K923559.

When did STERI-CATH MDI receive FDA 510(k) clearance?

STERI-CATH MDI received FDA 510(k) clearance on 1993-10-25, under 510(k) number K923559.

Who is the listed applicant for STERI-CATH MDI?

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

What is the FDA product code for STERI-CATH MDI?

The FDA product code for STERI-CATH MDI is CAF.

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Other records listing Concord/Portex 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.

K930218SUBCUTANEOUS TUNNELING NEEDLE AND HANDLESK924541EPIDURAL MINIPACKK930286DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITSK923127NEEDLE-PRO CARTRIDGEK923910HEAT MOISTURE CONDENSERK922749LOW PROFILE TRACHEOSTOMY TUBE

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Related Devices (Code: CAF)

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K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare 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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