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510(k) K853652

Device
BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT
Applicant
FISHER IMAGING CORP.
510(k) number
K853652
Product code
DRR  
Decision
Substantially Equivalent (SESE)
Decision date
1986-01-16
Date received
1985-09-03
Regulation
870.2050
Classification name
Amplifier And Signal Conditioner, Biopotential
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MURRAY BLOOM
Address
125 S. Fifth St. P.O. Box 0342 Reading PA US 19603 19603

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DRR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117Biocheck, Inc.2002-12-19
K971570EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391Quinton Electrophysiology Corp.1997-12-29
K925346EP AMP, MODEL #901Quinton Electrophysiology Corp.1993-04-30
K914381HORIZON 9000/HIS OPTION AMPLIFIERMennen Medical, Inc.1992-01-28
K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDGould, Inc.1991-07-22
K910307CARDIOLAB AMPLIFIER MODULE (CAM)Prucka Engineering, Inc.1991-04-12
K894735ASC-952 PHYSIOLOGICAL AMPLIFIERAstro-Med, Inc.1989-09-18
K894161ASC-950 ECG AMPLIFIERAstro-Med, Inc.1989-08-03
K874441BARD BIOPOTENTIAL AMPLIFIERC.R. Bard, Inc.1988-01-19
K813123EPC FILTERCodman & Shurtleff, Inc.1981-11-27
K810828NON-INVASIVE AMPLIFIERHenry Ford Hospital1981-04-10
K802686HP MODEL 8880A FILTERHewlett-Packard Co.1980-11-26
K802282ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CONConsolidated Medical Equipment, Inc.1980-10-10
K792283ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CONArzbaecher & Co.1979-11-21
K791964MODEL 15055A MAINFRAMEHewlett-Packard Co.1979-10-11

Legacy Summary#

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FDA Review#

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