FDA.reportPublic FDA data

510(k) K921184

Device
RLS 9100 RHINO-LARYNGEAL STROBOSCOPE
Applicant
KAY ELEMETRICS CORP.
510(k) number
K921184
Product code
EQL  
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-28
Date received
1992-03-09
Regulation
874.4750
Classification name
Laryngostroboscope
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM HARBESON
Address
12 Maple Ave. P.O. Box 2025 Pine Brook NJ US 07058 07058

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EQL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K984521RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351Richard Wolf Medical Instruments Corp.1999-03-17
K9212859105 RIGID TELESCOPIC ENDOSCOPEKay Elemetrics Corp.1992-05-28
K884933ENDOSTROBOSCOPE IVJedmed Instrument Co.1989-02-15
K842090RHINO-LARYNX STROBOSCOPE TYPE 4914Bruel & Kjaer Industri A/S1984-07-18
K822523LARYNGOSTROBOSCOPEKelleher Corp.1982-09-09
K801866PENTAX LARYNGO-STROBOSCOPE MODEL LS-1APentax Precision Instrument Corp.1980-09-16
K770466STOCKINGS, RVS TMParke-Davis Co.1977-03-28

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases