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FDA 510(k)

MABIS NB-02 ULTRASONIC NEBULIZER

K-Number: K990506 · 1999-03-11

ApplicantMabis Healthcare, Inc.
Decision Date1999-03-11
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MABIS NB-02 ULTRASONIC NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Mabis Healthcare, Inc.. It received FDA 510(k) clearance on 1999-03-11 under 510(k) number K990506. 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 MABIS NB-02 ULTRASONIC NEBULIZER?

MABIS NB-02 ULTRASONIC NEBULIZER is a medical device that received FDA 510(k) clearance on 1999-03-11. The listed applicant is Mabis Healthcare, Inc.. The 510(k) number is K990506.

When did MABIS NB-02 ULTRASONIC NEBULIZER receive FDA 510(k) clearance?

MABIS NB-02 ULTRASONIC NEBULIZER received FDA 510(k) clearance on 1999-03-11, under 510(k) number K990506.

Who is the listed applicant for MABIS NB-02 ULTRASONIC NEBULIZER?

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

What is the FDA product code for MABIS NB-02 ULTRASONIC NEBULIZER?

The FDA product code for MABIS NB-02 ULTRASONIC NEBULIZER is CAF.

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Other records listing Mabis Healthcare, 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.

K942072MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND

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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