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FDA 510(k)

MERITS HEALTH PRODUCTS PORTABLE NEBULIZER

K-Number: K053490 · 2006-07-24

ApplicantMerits Health Products Co., Ltd.
Decision Date2006-07-24
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MERITS HEALTH PRODUCTS PORTABLE NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Merits Health Products Co., Ltd.. It received FDA 510(k) clearance on 2006-07-24 under 510(k) number K053490. 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 MERITS HEALTH PRODUCTS PORTABLE NEBULIZER?

MERITS HEALTH PRODUCTS PORTABLE NEBULIZER is a medical device that received FDA 510(k) clearance on 2006-07-24. The listed applicant is Merits Health Products Co., Ltd.. The 510(k) number is K053490.

When did MERITS HEALTH PRODUCTS PORTABLE NEBULIZER receive FDA 510(k) clearance?

MERITS HEALTH PRODUCTS PORTABLE NEBULIZER received FDA 510(k) clearance on 2006-07-24, under 510(k) number K053490.

Who is the listed applicant for MERITS HEALTH PRODUCTS PORTABLE NEBULIZER?

The FDA 510(k) record lists Merits Health Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MERITS HEALTH PRODUCTS PORTABLE NEBULIZER?

The FDA product code for MERITS HEALTH PRODUCTS PORTABLE NEBULIZER is CAF.

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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

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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