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FDA 510(k)

ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR

K-Number: K972371 · 1997-08-19

ApplicantBrasamerica Medical Equipment, Inc.
Decision Date1997-08-19
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR is the device name listed in this FDA 510(k) record. The listed applicant is Brasamerica Medical Equipment, Inc.. It received FDA 510(k) clearance on 1997-08-19 under 510(k) number K972371. 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 ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR?

ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR is a medical device that received FDA 510(k) clearance on 1997-08-19. The listed applicant is Brasamerica Medical Equipment, Inc.. The 510(k) number is K972371.

When did ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR receive FDA 510(k) clearance?

ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR received FDA 510(k) clearance on 1997-08-19, under 510(k) number K972371.

Who is the listed applicant for ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR?

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

What is the FDA product code for ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR?

The FDA product code for ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR is CAF.

Related Clinical Trials

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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Other records listing Brasamerica Medical Equipment, 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.

K983736ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER

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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