FDA.reportPublic FDA data

510(k) K821269

Device
Tracheostomy Care Trays
Applicant
INTERMED, INC.
510(k) number
K821269
Product code
EQN
Decision
Substantially Equivalent (SESE)
Decision date
1982-05-27
Date received
1982-05-03
Regulation
874.4760
Classification name
Laryngoscope, Nasopharyngoscope
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EQN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252624KARL STORZ Laryngoscopes and AccessoriesKARL STORZ Endoscopy-America, Inc.2026-05-15
K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company2015-07-23
K132039ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIMJedmed Instrument Co.2014-02-21
K834172OP-CON SURG. INSTRUMENT #7Imm Enterprises , Ltd.1984-03-06
K831255LARYNGOSCOPE ATTACHMENT PH2000Eder Instrument Co, Inc.1983-09-12
K830888COOL-LITE FIBERCOPTIC LARYNGEAL EXAMNational Medical Technology1983-04-27
K822525LARYNGOSCOPES RIGIDKelleher Corp.1982-09-09
K821706NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGLKelleher Corp.1982-06-25
K821707NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHTKelleher Corp.1982-06-25
K821708NAGASHIMA LIGHT SOURCE UNIT SL-4Kelleher Corp.1982-06-25
K821709NAGASHIMA LIGHT SOURCE UNIT SL-5Kelleher Corp.1982-06-25
K821710NAGASHIMA NX-150F LIGHT SOURCE UNITKelleher Corp.1982-06-25
K821181FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE #Machida America, Inc.1982-05-13
K821182MODEL ENT-4L-FLEXIBLE NASOPHARYNGO-Machida America, Inc.1982-05-13
K813297CONPHAR LARYNGOSCOPEConphar, Inc.1982-01-22