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510(k) Data Aggregation
K Number
K102719Device Name
ATLANTEAN TRIGGER NEBULIZER
Manufacturer
Date Cleared
2011-07-01
(283 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
ATLANTEAN CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Atlantean Trigger Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
Device Description
The Atlantean Trigger Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended to only be use with FDA-approved drugs upon the specific direction of a physician. This device is not used with a specific drug nor is it distributed with such drugs.
The nebulizer has a trigger that allows the patient or clinician to activate the nebulizer which then generates respiratory size aerosolized liquids into gasses that are delivered directly to the patient This trigger function conserves medication and reduced environmental for breathing. contamination by medication. This nebulizer is also available with an attachable BFE/VFE filter that connects to the exhalation port of the nebulizer.
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K Number
K101568Device Name
MODEL SB100II FINGER PULSE OXIMETER
Manufacturer
Date Cleared
2010-09-20
(110 days)
Product Code
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
ATLANTEAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SB100II Fingertip Pulse Oximeter is a non-invasive device intended for the spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The SB100II is not intended for continuous monitoring.
Device Description
The SB10011 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a translucent part of the body, in this case the finger. This SB1001 contains the electronics to interface to the integral sensor. This sensor consists of a light emitting diode and a photoelectric cell placed on either side of the finger. Red and infrared light are transmitted through oxyhemoglobin and are sensed in the photoelectric cell. The red and infrared light is absorbed in different amounts depending on the oxygenation of the blood. The SB10011 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult and pediatric patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the SB100Il display digital values for both the SpO2 and Pulse. Pulse amplitude is displayed graphically by means of a vertical bar, which elevates in synch with the pulse cycle. The SB1001 is powered by two "AAA" batteries. The wavelength of red LED is 660nm and Infrared LED is 905/880nm with maximum optical output power of 4mW. The device incorporates a battery state indicator and provides a visual indication of low battery.
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