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FDA 510(k)

COMOACT ULTRASONIC NEBULIZER, MODEL 3060

K-Number: K002543 · 2001-06-14

ApplicantSan UP S.A.
Decision Date2001-06-14
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMOACT ULTRASONIC NEBULIZER, MODEL 3060 is the device name listed in this FDA 510(k) record. The listed applicant is San UP S.A.. It received FDA 510(k) clearance on 2001-06-14 under 510(k) number K002543. 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 COMOACT ULTRASONIC NEBULIZER, MODEL 3060?

COMOACT ULTRASONIC NEBULIZER, MODEL 3060 is a medical device that received FDA 510(k) clearance on 2001-06-14. The listed applicant is San UP S.A.. The 510(k) number is K002543.

When did COMOACT ULTRASONIC NEBULIZER, MODEL 3060 receive FDA 510(k) clearance?

COMOACT ULTRASONIC NEBULIZER, MODEL 3060 received FDA 510(k) clearance on 2001-06-14, under 510(k) number K002543.

Who is the listed applicant for COMOACT ULTRASONIC NEBULIZER, MODEL 3060?

The FDA 510(k) record lists San UP S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMOACT ULTRASONIC NEBULIZER, MODEL 3060?

The FDA product code for COMOACT ULTRASONIC NEBULIZER, MODEL 3060 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 San UP S.A. 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.

K002468SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050

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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