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FDA 510(k)

EZ-SPACER

K-Number: K933090 · 1994-02-10

ApplicantAirpharma, LLC
Decision Date1994-02-10
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EZ-SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Airpharma, LLC. It received FDA 510(k) clearance on 1994-02-10 under 510(k) number K933090. 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 EZ-SPACER?

EZ-SPACER is a medical device that received FDA 510(k) clearance on 1994-02-10. The listed applicant is Airpharma, LLC. The 510(k) number is K933090.

When did EZ-SPACER receive FDA 510(k) clearance?

EZ-SPACER received FDA 510(k) clearance on 1994-02-10, under 510(k) number K933090.

Who is the listed applicant for EZ-SPACER?

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

What is the FDA product code for EZ-SPACER?

The FDA product code for EZ-SPACER is CAF.

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.

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Other records listing Airpharma, LLC 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.

K964956E-Z SPACER MASK (SMALL)

Related Devices (Code: CAF)

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.

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

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