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FDA 510(k)

BAXTER NEBULIZER CAP MODEL 2D0868

K-Number: K962161 · 1996-08-15

ApplicantBaxter Healthcare Corp
Decision Date1996-08-15
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BAXTER NEBULIZER CAP MODEL 2D0868 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1996-08-15 under 510(k) number K962161. 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 BAXTER NEBULIZER CAP MODEL 2D0868?

BAXTER NEBULIZER CAP MODEL 2D0868 is a medical device that received FDA 510(k) clearance on 1996-08-15. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K962161.

When did BAXTER NEBULIZER CAP MODEL 2D0868 receive FDA 510(k) clearance?

BAXTER NEBULIZER CAP MODEL 2D0868 received FDA 510(k) clearance on 1996-08-15, under 510(k) number K962161.

Who is the listed applicant for BAXTER NEBULIZER CAP MODEL 2D0868?

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

What is the FDA product code for BAXTER NEBULIZER CAP MODEL 2D0868?

The FDA product code for BAXTER NEBULIZER CAP MODEL 2D0868 is CAF.

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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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