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FDA 510(k)

NEB-90 LARGE VOLUME MEDICATION NEBULIZER

K-Number: K080657 · 2008-06-30

ApplicantMedi Nuclear Corp., Inc.
Decision Date2008-06-30
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEB-90 LARGE VOLUME MEDICATION NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Medi Nuclear Corp., Inc.. It received FDA 510(k) clearance on 2008-06-30 under 510(k) number K080657. 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 NEB-90 LARGE VOLUME MEDICATION NEBULIZER?

NEB-90 LARGE VOLUME MEDICATION NEBULIZER is a medical device that received FDA 510(k) clearance on 2008-06-30. The listed applicant is Medi Nuclear Corp., Inc.. The 510(k) number is K080657.

When did NEB-90 LARGE VOLUME MEDICATION NEBULIZER receive FDA 510(k) clearance?

NEB-90 LARGE VOLUME MEDICATION NEBULIZER received FDA 510(k) clearance on 2008-06-30, under 510(k) number K080657.

Who is the listed applicant for NEB-90 LARGE VOLUME MEDICATION NEBULIZER?

The FDA 510(k) record lists Medi Nuclear Corp., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEB-90 LARGE VOLUME MEDICATION NEBULIZER?

The FDA product code for NEB-90 LARGE VOLUME MEDICATION NEBULIZER is CAF.

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Other records listing Medi Nuclear Corp., Inc. 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.

K082541HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEMK080969HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510K915075NEBULIZER (DIRECT PATIENT INTERFACE)K865107AERO-VENT AEROSOL UNITK865093SAFE-T-SHIELD MOUTHPIECEK863996MODEL XE-103 XENON/MASTER II

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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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