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DRR — Amplifier And Signal Conditioner, Biopotential Class II

FDA Device Classification

Classification Details

Product Code
DRR
Device Class
Class II
Regulation Number
870.2050
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
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K894735astro-medASC-952 PHYSIOLOGICAL AMPLIFIERSeptember 18, 1989
K894161astro-medASC-950 ECG AMPLIFIERAugust 3, 1989
K874441c.r. bardBARD BIOPOTENTIAL AMPLIFIERJanuary 19, 1988
K853652fisher imagingBERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUTJanuary 16, 1986
K813123codman and shurtleffEPC FILTERNovember 27, 1981
K810828henry ford hospitalNON-INVASIVE AMPLIFIERApril 10, 1981
K802686hewlett-packardHP MODEL 8880A FILTERNovember 26, 1980
K802282consolidated medical equipmentESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CONOctober 10, 1980
K792283arzbaecher andESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CONNovember 21, 1979
K791964hewlett-packardMODEL 15055A MAINFRAMEOctober 11, 1979
K790203electronics for medicineINTERVAL TIMER MODEL V4295March 2, 1979
K780572c-v monitorsDCG PREAMPLIFIER MODULEMay 9, 1978
K780043datascopeESIS MODULEFebruary 13, 1978
K772132hewlett-packardAMPLIFIER MODULE, 78211A ECGNovember 22, 1977