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FDA 510(k)

MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES

K-Number: K041327 · 2004-07-20

ApplicantMed2000 S.R.L.
Decision Date2004-07-20
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Med2000 S.R.L.. It received FDA 510(k) clearance on 2004-07-20 under 510(k) number K041327. 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 MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES?

MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES is a medical device that received FDA 510(k) clearance on 2004-07-20. The listed applicant is Med2000 S.R.L.. The 510(k) number is K041327.

When did MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES receive FDA 510(k) clearance?

MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES received FDA 510(k) clearance on 2004-07-20, under 510(k) number K041327.

Who is the listed applicant for MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES?

The FDA 510(k) record lists Med2000 S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES?

The FDA product code for MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES 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 Med2000 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.

K041974MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZERK031908MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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