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FDA 510(k)

PREEMICARE NEBUTECH NEBULIZER SYSTEM

K-Number: K896375 · 1990-10-29

ApplicantPreemicare Corp.
Decision Date1990-10-29
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PREEMICARE NEBUTECH NEBULIZER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Preemicare Corp.. It received FDA 510(k) clearance on 1990-10-29 under 510(k) number K896375. 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 PREEMICARE NEBUTECH NEBULIZER SYSTEM?

PREEMICARE NEBUTECH NEBULIZER SYSTEM is a medical device that received FDA 510(k) clearance on 1990-10-29. The listed applicant is Preemicare Corp.. The 510(k) number is K896375.

When did PREEMICARE NEBUTECH NEBULIZER SYSTEM receive FDA 510(k) clearance?

PREEMICARE NEBUTECH NEBULIZER SYSTEM received FDA 510(k) clearance on 1990-10-29, under 510(k) number K896375.

Who is the listed applicant for PREEMICARE NEBUTECH NEBULIZER SYSTEM?

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

What is the FDA product code for PREEMICARE NEBUTECH NEBULIZER SYSTEM?

The FDA product code for PREEMICARE NEBUTECH NEBULIZER SYSTEM is CAF.

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Other records listing Preemicare Corp. 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.

K911450INFANT VENTILATORK900735MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATORK893622PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.K893624PREEMICARE MODEL 2500 TRANSPORT WARMERK891674NEONATAL ENVIRONMENTAL MONITOR, MODEL 275K885350PREEMICARE SERIES 2000 INFANT WARMER

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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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