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510(k) Data Aggregation
K Number
K983736Device Name
ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER
Manufacturer
Date Cleared
1998-11-10
(19 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
BRASAMERICA MEDICAL EQUIPMENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This ultrasonic nebulizer is intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing for use by both the adult and pediatric populations.
Device Description
The ICEL Evolusonic Portable Ultrasonic Nebulizer has been developed with the patient's necessities in mind for the delivery of spray liquids in aerosol form into gases directly to the patient for breathing, for use by the adult and pediatric populations. The device runs on standard AC power and easily upgrades to battery operation (rechargeable battery or sold separately). It can be plugged into an electrical outlet using the AC/DC converter, and it can also be plugged directly into an automobile cigarette lighter for use when traveling.
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K Number
K972371Device Name
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR
Manufacturer
Date Cleared
1997-08-19
(55 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
BRASAMERICA MEDICAL EQUIPMENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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