Product code KLX— Ear, Nose, Throat

FDA has cleared 4 devices under product code KLX between 1982 and 1999, filed by 4 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.

• 19991 clearance
• 19901 clearance
• 19841 clearance
• 19821 clearance

• Teltec Electronic Equipment AB1 clearance
• Ms. Kate Teaney1 clearance
• Kay Elemetrics Corp.1 clearance
• Glottal Ent., Inc.1 clearance

• K990240 — ELECTROGLOTTOGRAPHKay Elemetrics Corp.·1999-03-11
• K901609 — ELECTROGLOTTOGRAPHGlottal Ent., Inc.·1990-06-28
• K841832 — GLOTTAL FREQUENCY ANALYSERTeltec Electronic Equipment AB·1984-07-18
• K821079 — ELECTROGLOTTOGRAPH NAKED EGG BOXED EGGMs. Kate Teaney·1982-05-10