Nihon Kohden America, Inc.
Nihon Kohden America, Inc. holds FDA 510(k) medical device clearances, first cleared 1979, most recent 2012, with 10 FDA device recalls on record.
Clearances by Nihon Kohden America, Inc. — page 2
101–166 of 166- K865030 — CARDIOFAX-V ECG-8240A
- K865032 — CARDIOFAX-V ECG-834OA
- K854371 — MTC 6210A CARDIAC OUTPUT COMPUTER
- K865031 — ELECTROCARDIOGRAPH
- K862462 — LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC
- K862463 — LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
- K862799 — SKIN PURE
- K863404 — CARDIOLIFE TEC 7100
- K863405 — CARDIOLIFE TEC 7200
- K863116 — CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH)
- K860237 — OMF-7101 FETAL MONITOR
- K854662 — OEE_7102 EEG/TREND MONITOR
- K854663 — NEUROFAX 7310 SERIES (EEG)
- K854664 — MEB-5200
- K860210 — ELEFIX ELECTRODE CREAM
- K860239 — ORG-7201 MULTIPARAMETER TELEMETRY MONITOR
- K854665 — 4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH
- K854370 — MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR
- K860212 — CARDIOFAX ECG-6353
- K854866 — LONG TERM RECORDER RAG 1200
- K854369 — WEP 7604 TELEMETRY MONITOR
- K854372 — VM 781 SLAVE SCOPE
- K852270 — LIFESCOPE 8 DEC-8108A AND DEC-8204A
- K851300 — NEUROPACK 8, MEE-4108
- K850343 — DISPLAY MONITOR (VD-711RA-VD-712RA)
- K844911 — ARRHYTHMIA CENTRAL-OGP-7201
- K842381 — SLS 3500 LED VISUAL STIMULATOR
- K843287 — ARRHYTHMIA CENTRAL OCC-7101
- K842714 — EEG-4300 W/OPTINAL ACCESS. EEG 4314 &
- K841499 — LIFESCOPE II
- K841500 — LIFESCOPE 6 OEC-6201
- K841501 — LIFESCOPE 6 OEC-6102
- K841502 — LIFESCOPE 6 OEC-6105
- K841497 — NEUROPACK 8 MEE 4108
- K841612 — NEUROPACK II 5100
- K840258 — TEC-3500 DEFIBRILLATOR
- K841498 — C02 MONITOR-OIR-7101
- K840274 — CARDIOFAX ECG 6543
- K831274 — WLECTROCARDIOGRAPH ECG-7204
- K831324 — EEG 42/2P ELECTRO ENCEPHALOGRAPH
- K823562 — EMG MODULES FOR POLYGRAPH SYSTEM
- K823563 — EEG & RESPIRATION MODULES POLYGRAPH
- K823561 — URETHRAL PRESSURE PROFILE & TEMP. MODUL
- K823281 — MODEL RM 6000, 6100,6200 POLYGRAPH
- K823140 — ELECTROENCEPHALOGRAPH
- K823220 — COSMOS
- K823249 — LIFESCOPE II/FOUR
- K820742 — NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100
- K820067 — ELECTROENCEPHALOGRAPH ECG-6151
- K820066 — ELECTROENCEPHALOGRAPHS EEG-5208,5210
- K813266 — NIHON KOHDEN ELECTROCARDIOGRAPH
- K813444 — NIHON KOHDEN HEART MONITORS OMP 7101-02
- K810712 — ELECTRONIC SPIROMETER MODEL MFR-8100
- K810357 — STRESS TEST SYSTEM
- K802887 — MODEL EEG 4221
- K802305 — MLC-4200 CARDIAC OUTPUT COMPUTER
- K801677 — ELECTROCARDIOGRAPH, MODEL ECG-5503
- K800004 — ECG MONITOR OSCILLOSCOPE MODEL OEC-3200
- K800005 — ECG MONITOR OSCILLOSCOPE MODEL OEC-3100
- K792678 — CARDIAC OUTPUT COMPUTER, M-MLC-4100
- K792229 — ELECTROCARDIOGRAPH, MODEL ECG-5151
- K791149 — STIMULATOR MODEL SSS-1101
- K791150 — ELECTROENCEPHALOGRAPHS MODELS 7209,7213
- K791233 — MODEL EEG-4214 ELECTROENCEPHALOGRAPH
- K791234 — MODEL EEG-4217 ELECTROENCEPHALOGRAPH
- K791540 — ELECTROCARDIOGRAPH MODEL ECG-5403
Data sourced from openFDA. This site is unofficial and independent of the FDA.