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510(k) Data Aggregation
K Number
K051779Device Name
ANDROFLOW - RESPIRATORY RATE MONITOR
Manufacturer
ANDROMED, INC.
Date Cleared
2005-09-30
(91 days)
Product Code
BZQ
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
ANDROMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Androflo™ is intended for use as an adjunct to patient assessment in continuous monitoring of respiratory rate (breathing frequency).
Androflo™ is indicated for clinical use in adult patients under the supervision of qualified health care professionals trained in the use of the equipment.
Androflo™ is not intended for home use or for use as an apnea monitor.
Device Description
Not Found
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K Number
K021389Device Name
BIOLOGICAL SOUND MONITOR (BSM) SENSOR
Manufacturer
ANDROMED, INC.
Date Cleared
2002-10-01
(152 days)
Product Code
DQD, DOD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
ANDROMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biological Sound Monitor Sensor is intended for the purpose of capturing, detecting and transmitting biological sounds such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The Biological Sound Monitor Sensor may be used with any compatible devices that may amplify biological sound signals for auscultation, display or further processing.
The Biological Sound Monitor Sensor is indicated for use with children and adults under the supervision of a physician or other trained health care professional. It is indicated for use during routine exam in clinical or other suitably prescribed environment in conjunction with such devices as an electronic stethoscope.
In no way are any of the sensor functions represented as being in and of themselves diagnostic. Sound signals must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.
Device Description
Biological Sound Monitor (BSM) Sensor
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K Number
K022298Device Name
I-STETHOS LINK
Manufacturer
ANDROMED, INC.
Date Cleared
2002-10-01
(77 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
ANDROMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The i-Stethos Link Electronic Stethoscope is intended for the purpose of electronically amplifying and listening to biological sounds, such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The i-Stethos Link may also be used to display the heart rate, which is calculated as the number of heartbeats per minute.
In addition, the i-Stethos Link is equipped with an analog I/O port to interface with external devices such as a computer and to accept input from other compatible devices such as the biological sound monitor (BSM) sensor or another i-Stethos Link.
The i-Stethos Link Electronic Stethoscope is indicated for use under the same conditions that would otherwise require the use of an acoustic (non-electronic) stethoscope.
The i-Stethos Link Electronic Stethoscope is not intended as a substitute for medical care or for diagnosis and treatment by unlicensed or unqualified persons.
Device Description
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K Number
K010729Device Name
AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A
Manufacturer
ANDROMED, INC.
Date Cleared
2001-10-26
(228 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
ANDROMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001306Device Name
STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX
Manufacturer
ANDROMED, INC.
Date Cleared
2000-07-20
(86 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
ANDROMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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