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510(k) Data Aggregation
K Number
K961972Device Name
MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
Manufacturer
AEQUITRON MEDICAL, INC.
Date Cleared
1997-04-18
(333 days)
Product Code
BZQ
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
AEQUITRON MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use of the Ami Infant Central ApnealHeart Rate Monitor is indicated for the continuous monitoring of an infant's heart rate and respiration rate in a home, hospital or portable environment. Continuous monitoring is indicated for infants whose physical condition may result or has resulted in an instability in heart rate or respiration which may become detrimental to the infant. Conditions which may require monitoring include (not all inclusive): Prematurity, Respiratory dysfunction, Neurologic dysfunction, Maternal drug abuse, Cardiovascular dysfunction.
Device Description
The Ami Infant Central ApnealHeart Rate Monitor is capable of monitoring an infant's respiratory and heart rates. The device utilizes respiration detection technology for respiratory effort detection and also detects ECG rate through the same two electrodes. The device also incorporates auxiliary inputs for recording stand-alone oximeter output parameters and/or other devices' signal outputs within specified parameters. The device operates off either battery of AC power.
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K Number
K952880Device Name
MODEL LP-1000 VOLUME VENTILATOR
Manufacturer
AEQUITRON MEDICAL, INC.
Date Cleared
1996-06-20
(364 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
AEQUITRON MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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