Product code LLN— Neurology

FDA has cleared 13 devices under product code LLN between 1984 and 2009, filed by 13 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.

• 20091 clearance
• 20031 clearance
• 20011 clearance
• 19973 clearances
• 19941 clearance
• 19922 clearances
• 19871 clearance
• 19862 clearances
• 19841 clearance

• Xilas Medical, Inc.1 clearance
• Wr Medical Electronics Co.1 clearance
• Topical Testing, Inc.1 clearance
• Teca, Inc.1 clearance
• Somedic AB1 clearance
• Sensortek, Inc.1 clearance
• Pentax Precision Instrument Corp.1 clearance
• Osachi Co., Ltd.1 clearance
• Nk Biotechnical Engineering Co.1 clearance
• Neurotron, Inc.1 clearance

• K072882 — PAIN VISION, MODEL PS-2100Osachi Co., Ltd.·2009-01-08
• K030829 — VPT METERXilas Medical, Inc.·2003-12-05
• K010981 — GSA GENITO SENSORY ANALYZERMedoc Ltd. Advanced Medical Systems·2001-09-20
• K964622 — MEDI-DX 7000Neuro-Diagnostic Assoc.·1997-12-01
• K964815 — AP-4000, AIR PULSE SENSORY STIMULATORPentax Precision Instrument Corp.·1997-09-04
• K970180 — VSA 3000 VIBRATORYN SENSORY ANALYZEREare Consulting Service·1997-04-25
• K934368 — NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001Nk Biotechnical Engineering Co.·1994-08-11
• K921560 — VIBROTACTILE TESTER, MODEL NO. VTT-100Topical Testing, Inc.·1992-10-30
• K910624 — CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4Wr Medical Electronics Co.·1992-01-17
• K872931 — TECA/MEDELEC TTT THERMAL THRESHOLD TESTERTeca, Inc.·1987-11-16
• K863607 — VIBRATRON II, VIBRATION SENSITIVITY TESTERSensortek, Inc.·1986-12-03
• K853608 — NEUROMETERNeurotron, Inc.·1986-06-12
• K843486 — VIBRAMETERSomedic AB·1984-12-24