FDA 510(k) Applications for Medical Device Product Code "DRR"
(Amplifier And Signal Conditioner, Biopotential)

FDA 510(k) Number Applicant Device Name Decision Date
K792283 ARZBAECHER & CO. ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON 11/21/1979
K894161 ASTRO-MED, INC. ASC-950 ECG AMPLIFIER 08/03/1989
K894735 ASTRO-MED, INC. ASC-952 PHYSIOLOGICAL AMPLIFIER 09/18/1989
K022660 BIOCHECK, INC. BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 12/19/2002
K780572 C-V MONITORS CORP. DCG PREAMPLIFIER MODULE 05/09/1978
K874441 C.R. BARD, INC. BARD BIOPOTENTIAL AMPLIFIER 01/19/1988
K770243 CARDIAC PACEMAKERS, INC. ELGILOY STYLET 02/14/1977
K813123 CODMAN & SHURTLEFF, INC. EPC FILTER 11/27/1981
K802282 CONSOLIDATED MEDICAL EQUIPMENT, INC. ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON 10/10/1980
K780043 DATASCOPE CORP. ESIS MODULE 02/13/1978
K790203 ELECTRONICS FOR MEDICINE, INC. INTERVAL TIMER MODEL V4295 03/02/1979
K853652 FISHER IMAGING CORP. BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT 01/16/1986
K771976 G.D. SEARLE AND CO. ECG AMPLIFIER/R WAVE TRIGGER 11/09/1977
K911935 GOULD, INC. CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED 07/22/1991
K810828 HENRY FORD HOSPITAL NON-INVASIVE AMPLIFIER 04/10/1981
K772132 HEWLETT-PACKARD CO. AMPLIFIER MODULE, 78211A ECG 11/22/1977
K761056 HEWLETT-PACKARD CO. DISPLAY MONITOR (MODEL 78301A) 12/09/1976
K802686 HEWLETT-PACKARD CO. HP MODEL 8880A FILTER 11/26/1980
K791964 HEWLETT-PACKARD CO. MODEL 15055A MAINFRAME 10/11/1979
K771572 HEWLETT-PACKARD CO. PATIENT MONITORS MODELS 78701A/78702A 08/30/1977
K914381 MENNEN MEDICAL, INC. HORIZON 9000/HIS OPTION AMPLIFIER 01/28/1992
K910307 PRUCKA ENGINEERING, INC. CARDIOLAB AMPLIFIER MODULE (CAM) 04/12/1991
K925346 QUINTON ELECTROPHYSIOLOGY CORP. EP AMP, MODEL #901 04/30/1993
K971570 QUINTON ELECTROPHYSIOLOGY CORP. EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 12/29/1997


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