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EQN — Laryngoscope, Nasopharyngoscope Class II

FDA Device Classification

Classification Details

Product Code
EQN
Device Class
Class II
Regulation Number
874.4760
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Definition

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K150248jedmed instrumentORL Video NasoPharyngo-LarngoscopeJuly 23, 2015
K132039jedmed instrumentERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIMFebruary 21, 2014
K834172imm enterprisesOP-CON SURG. INSTRUMENT #7March 6, 1984
K831255eder instrument coLARYNGOSCOPE ATTACHMENT PH2000September 12, 1983
K830888national medical technologyCOOL-LITE FIBERCOPTIC LARYNGEAL EXAMApril 27, 1983
K822525kelleherLARYNGOSCOPES RIGIDSeptember 9, 1982
K821710kelleherNAGASHIMA NX-150F LIGHT SOURCE UNITJune 25, 1982
K821707kelleherNAGASHIMA SFT-II LARYNGOSCOPE STRAIGHTJune 25, 1982
K821706kelleherNAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGLJune 25, 1982
K821708kelleherNAGASHIMA LIGHT SOURCE UNIT SL-4June 25, 1982
K821709kelleherNAGASHIMA LIGHT SOURCE UNIT SL-5June 25, 1982
K821269intermedTRACHEOSTOMY CARE TRAYSMay 27, 1982
K821181machida americaFLEXIBLE NASOPHARYNGO-LARYNGOSCOPE #May 13, 1982
K821182machida americaMODEL ENT-4L-FLEXIBLE NASOPHARYNGO-May 13, 1982
K813297conpharCONPHAR LARYNGOSCOPEJanuary 22, 1982
K812734machida americaMACHIDA FLEXIBLE INTUBATION SCOPE FLS-POctober 19, 1981
K811943machida americaMACHIDA NASOPHARYNGO-LARYNGOSCOPEJuly 28, 1981
K792222shileySHILEY LOW PRESSURE THIN-CUFFED TRACH.December 18, 1979
K782002kinetic conceptsTRACH-COLLARDecember 15, 1978
K781639shileySHILEY CRICOTHYROTOMY TUBEOctober 24, 1978