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DRR — Amplifier And Signal Conditioner, Biopotential Class II

FDA Device Classification

FDA product code DRR covers "Amplifier And Signal Conditioner, Biopotential", a Class II medical device regulated under 21 CFR 870.2050. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification details

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

Recent 510(k) clearances

K-NumberApplicantDevice NameDate
K022660BiocheckBIOCHECK MYOGLOBIN ELISA, MODEL BC-1117Dec 19, 2002
K971570Quinton ElectrophysiologyEPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391Dec 29, 1997
K925346Quinton ElectrophysiologyEP AMP, MODEL #901Apr 30, 1993
K914381Mennen MedicalHORIZON 9000/HIS OPTION AMPLIFIERJan 28, 1992
K911935GouldCARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDJul 22, 1991
K910307Prucka EngineeringCARDIOLAB AMPLIFIER MODULE (CAM)Apr 12, 1991
K894735Astro-MedASC-952 PHYSIOLOGICAL AMPLIFIERSep 18, 1989
K894161Astro-MedASC-950 ECG AMPLIFIERAug 3, 1989
K874441C.R. BardBARD BIOPOTENTIAL AMPLIFIERJan 19, 1988
K853652Fisher ImagingBERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUTJan 16, 1986
K813123Codman And ShurtleffEPC FILTERNov 27, 1981
K810828Henry Ford HospitalNON-INVASIVE AMPLIFIERApr 10, 1981
K802686Hewlett-PackardHP MODEL 8880A FILTERNov 26, 1980
K802282Consolidated Medical EquipmentESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CONOct 10, 1980
K792283Arzbaecher AndESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CONNov 21, 1979
K791964Hewlett-PackardMODEL 15055A MAINFRAMEOct 11, 1979
K790203Electronics For MedicineINTERVAL TIMER MODEL V4295Mar 2, 1979
K780572C-V MonitorsDCG PREAMPLIFIER MODULEMay 9, 1978
K780043DatascopeESIS MODULEFeb 13, 1978
K772132Hewlett-PackardAMPLIFIER MODULE, 78211A ECGNov 22, 1977

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.