Product code DRR— Cardiovascular

FDA has cleared 24 devices under product code DRR between 1976 and 2002, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20021 clearance
• 19971 clearance
• 19931 clearance
• 19921 clearance
• 19912 clearances
• 19892 clearances
• 19881 clearance
• 19861 clearance
• 19812 clearances
• 19802 clearances
• 19793 clearances
• 19782 clearances
• 19774 clearances
• 19761 clearance

• Hewlett-Packard Co.5 clearances
• Quinton Electrophysiology Corp.2 clearances
• Astro-Med, Inc.2 clearances
• Prucka Engineering, Inc.1 clearance
• Mennen Medical, Inc.1 clearance
• Henry Ford Hospital1 clearance
• Gould, Inc.1 clearance
• G.D. Searle and Co.1 clearance
• Fisher Imaging Corp.1 clearance
• Electronics For Medicine, Inc.1 clearance

• K022660 — BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117Biocheck, Inc.·2002-12-19
• K971570 — EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391Quinton Electrophysiology Corp.·1997-12-29
• K925346 — EP AMP, MODEL #901Quinton Electrophysiology Corp.·1993-04-30
• K914381 — HORIZON 9000/HIS OPTION AMPLIFIERMennen Medical, Inc.·1992-01-28
• K911935 — CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDGould, Inc.·1991-07-22
• K910307 — CARDIOLAB AMPLIFIER MODULE (CAM)Prucka Engineering, Inc.·1991-04-12
• K894735 — ASC-952 PHYSIOLOGICAL AMPLIFIERAstro-Med, Inc.·1989-09-18
• K894161 — ASC-950 ECG AMPLIFIERAstro-Med, Inc.·1989-08-03
• K874441 — BARD BIOPOTENTIAL AMPLIFIERC.R. Bard, Inc.·1988-01-19
• K853652 — BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUTFisher Imaging Corp.·1986-01-16
• K813123 — EPC FILTERCodman & Shurtleff, Inc.·1981-11-27
• K810828 — NON-INVASIVE AMPLIFIERHenry Ford Hospital·1981-04-10
• K802686 — HP MODEL 8880A FILTERHewlett-Packard Co.·1980-11-26
• K802282 — ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CONConsolidated Medical Equipment, Inc.·1980-10-10
• K792283 — ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CONArzbaecher & Co.·1979-11-21
• K791964 — MODEL 15055A MAINFRAMEHewlett-Packard Co.·1979-10-11
• K790203 — INTERVAL TIMER MODEL V4295Electronics For Medicine, Inc.·1979-03-02
• K780572 — DCG PREAMPLIFIER MODULEC-V Monitors Corp.·1978-05-09
• K780043 — ESIS MODULEDatascope Corp.·1978-02-13
• K772132 — AMPLIFIER MODULE, 78211A ECGHewlett-Packard Co.·1977-11-22
• K771976 — ECG AMPLIFIER/R WAVE TRIGGERG.D. Searle and Co.·1977-11-09
• K771572 — PATIENT MONITORS MODELS 78701A/78702AHewlett-Packard Co.·1977-08-30
• K770243 — ELGILOY STYLETCardiac Pacemakers, Inc.·1977-02-14
• K761056 — DISPLAY MONITOR (MODEL 78301A)Hewlett-Packard Co.·1976-12-09