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FDA 510(k)

OMRON ULTRASONIC NEBULIZER MODEL NE-UO5

K-Number: K864466 · 1987-03-26

ApplicantOmron Tateisi Electronics Co.
Decision Date1987-03-26
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OMRON ULTRASONIC NEBULIZER MODEL NE-UO5 is the device name listed in this FDA 510(k) record. The listed applicant is Omron Tateisi Electronics Co.. It received FDA 510(k) clearance on 1987-03-26 under 510(k) number K864466. 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 OMRON ULTRASONIC NEBULIZER MODEL NE-UO5?

OMRON ULTRASONIC NEBULIZER MODEL NE-UO5 is a medical device that received FDA 510(k) clearance on 1987-03-26. The listed applicant is Omron Tateisi Electronics Co.. The 510(k) number is K864466.

When did OMRON ULTRASONIC NEBULIZER MODEL NE-UO5 receive FDA 510(k) clearance?

OMRON ULTRASONIC NEBULIZER MODEL NE-UO5 received FDA 510(k) clearance on 1987-03-26, under 510(k) number K864466.

Who is the listed applicant for OMRON ULTRASONIC NEBULIZER MODEL NE-UO5?

The FDA 510(k) record lists Omron Tateisi Electronics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMRON ULTRASONIC NEBULIZER MODEL NE-UO5?

The FDA product code for OMRON ULTRASONIC NEBULIZER MODEL NE-UO5 is CAF.

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Other records listing Omron Tateisi Electronics Co. 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

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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