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FDA 510(k)

FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001

K-Number: K101552 · 2011-03-14

ApplicantFoshan Care Medical Technology Co., Ltd.
Decision Date2011-03-14
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Care Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2011-03-14 under 510(k) number K101552. 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 FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001?

FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 is a medical device that received FDA 510(k) clearance on 2011-03-14. The listed applicant is Foshan Care Medical Technology Co., Ltd.. The 510(k) number is K101552.

When did FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 receive FDA 510(k) clearance?

FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 received FDA 510(k) clearance on 2011-03-14, under 510(k) number K101552.

Who is the listed applicant for FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001?

The FDA 510(k) record lists Foshan Care Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001?

The FDA product code for FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 is CAF.

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Other records listing Foshan Care Medical Technology Co., Ltd. as applicant

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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

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