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FDA 510(k)

HEART NEBULIZER FLOWMETER ADAPTOR

K-Number: K913015 · 1991-11-20

ApplicantB&B Medical Technologies, Inc.
Decision Date1991-11-20
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEART NEBULIZER FLOWMETER ADAPTOR is the device name listed in this FDA 510(k) record. The listed applicant is B&B Medical Technologies, Inc.. It received FDA 510(k) clearance on 1991-11-20 under 510(k) number K913015. 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 HEART NEBULIZER FLOWMETER ADAPTOR?

HEART NEBULIZER FLOWMETER ADAPTOR is a medical device that received FDA 510(k) clearance on 1991-11-20. The listed applicant is B&B Medical Technologies, Inc.. The 510(k) number is K913015.

When did HEART NEBULIZER FLOWMETER ADAPTOR receive FDA 510(k) clearance?

HEART NEBULIZER FLOWMETER ADAPTOR received FDA 510(k) clearance on 1991-11-20, under 510(k) number K913015.

Who is the listed applicant for HEART NEBULIZER FLOWMETER ADAPTOR?

The FDA 510(k) record lists B&B Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEART NEBULIZER FLOWMETER ADAPTOR?

The FDA product code for HEART NEBULIZER FLOWMETER ADAPTOR is CAF.

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Other records listing B&B Medical Technologies, 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.

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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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