Product code GWS— Neurology

FDA has cleared 15 devices under product code GWS between 1980 and 1998, filed by 12 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19981 clearance
• 19931 clearance
• 19911 clearance
• 19901 clearance
• 19872 clearances
• 19863 clearances
• 19852 clearances
• 19841 clearance
• 19811 clearance
• 19802 clearances

• Cns, Inc.3 clearances
• Neuroscience, Inc.2 clearances
• Teca, Inc.1 clearance
• Stellate Systems1 clearance
• Persyst Development Corp.1 clearance
• Nihon Kohden America, Inc.1 clearance
• Nicolet Instrument Corp.1 clearance
• Neurometrics1 clearance
• Grass-Telefactor Product Group1 clearance
• Dade Medical, Inc.1 clearance

• K974718 — PERSYST PRISMPersyst Development Corp.·1998-03-09
• K925735 — EEG ANALYZERBio-Scan, Inc.·1993-12-03
• K912938 — RHYTHMStellate Systems·1991-07-30
• K894629 — NICOLET BEAM II SYSTEMNicolet Instrument Corp.·1990-03-09
• K871931 — ISTAT SOFTWARENeuroscience, Inc.·1987-10-13
• K871480 — STD-228 SPECTRAL TREND DISPLAYGrass-Telefactor Product Group·1987-05-01
• K854662 — OEE_7102 EEG/TREND MONITORNihon Kohden America, Inc.·1986-08-20
• K860829 — CNS 4/8 AND CT 48.1 SOFTWARECns, Inc.·1986-05-29
• K854160 — CNS-16 & LTM 1.0 SOFTWARECns, Inc.·1986-01-10
• K850430 — NEUROSCIENCE MAP-10 EEGNeuroscience, Inc.·1985-07-17
• K844481 — NEUROLAB IITeca, Inc.·1985-05-20
• K844015 — CEREBRAL TRACER 1500 & CT 1.0 SOFTWARECns, Inc.·1984-12-17
• K803233 — MEUROMETRICS MONITORDade Medical, Inc.·1981-01-12
• K800452 — NEUROMETRICS MONITORNeurometrics·1980-04-02
• K800001 — MINI-CEARS COMPUTER (MODEL 1)Bik Foundation, Inc.·1980-01-31