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FDA 510(k) Applications Submitted by ANDROMED, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K021389
05/02/2002
BIOLOGICAL SOUND MONITOR (BSM) SENSOR
ANDROMED, INC.
K022298
07/16/2002
I-STETHOS LINK
ANDROMED, INC.
K051779
07/01/2005
ANDROFLOW - RESPIRATORY RATE MONITOR
ANDROMED, INC.
K001306
04/25/2000
STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX
ANDROMED, INC.
K010729
03/12/2001
AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A
ANDROMED, INC.
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