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FDA 510(k)

MASTER NEB II

K-Number: K970542 · 1997-06-24

ApplicantBremed Italia, S.R.L.
Decision Date1997-06-24
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MASTER NEB II is the device name listed in this FDA 510(k) record. The listed applicant is Bremed Italia, S.R.L.. It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K970542. 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 MASTER NEB II?

MASTER NEB II is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Bremed Italia, S.R.L.. The 510(k) number is K970542.

When did MASTER NEB II receive FDA 510(k) clearance?

MASTER NEB II received FDA 510(k) clearance on 1997-06-24, under 510(k) number K970542.

Who is the listed applicant for MASTER NEB II?

The FDA 510(k) record lists Bremed Italia, S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MASTER NEB II?

The FDA product code for MASTER NEB II 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 Bremed Italia, S.R.L. 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.

K982043BRENEBK974379ULTRANEB

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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