Cool-Lite Fibercoptic Laryngeal Exam

FDA 510(k) K830888 · National Medical Technology

Substantially Equivalent

510(k) numberK830888

Submission

Device name
Cool-Lite Fibercoptic Laryngeal Exam
Applicant
National Medical Technology
Mchenry, IL, US
Received
March 21, 1983
Decision date
April 27, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EQN – Laryngoscope, Nasopharyngoscope
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4760
Specialty
Ear, Nose, Throat

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).

Other 510(k)s with product code EQN

510(k)DeviceApplicantDecision
K252624KARL STORZ Laryngoscopes and AccessoriesEQN · Traditional KARL STORZ Endoscopy-America, Inc.05/15/2026SE
K150248ORL Video NasoPharyngo-LarngoscopeEQN · Traditional Jedmed Instrument Company07/23/2015SE
K132039Ergo-Flex Laryngo-Nasopharyngoscope Ef-N and Ef-N SlimEQN · Traditional Jedmed Instrument Co.02/21/2014SE
K834172Op-Con Surg. Instrument #7EQN · Traditional Imm Enterprises , Ltd.03/06/1984SE
K831255Laryngoscope Attachment PH2000EQN · Traditional Eder Instrument Co, Inc.09/12/1983SE
K822525Laryngoscopes RigidEQN · Traditional Kelleher Corp.09/09/1982SE
K821710Nagashima NX-150F Light Source UnitEQN · Traditional Kelleher Corp.06/25/1982SE
K821709Nagashima Light Source Unit SL-5EQN · Traditional Kelleher Corp.06/25/1982SE
K821708Nagashima Light Source Unit SL-4EQN · Traditional Kelleher Corp.06/25/1982SE
K821707Nagashima Sft-Ii Laryngoscope StraightEQN · Traditional Kelleher Corp.06/25/1982SE

More from Kelleher Corp.

510(k)DeviceDecision
K871668Biodan Type Comet ElectrodeDRX · Traditional 06/10/1987SE
K861158S&W Type 888 ElectrodeDRX · Traditional 07/01/1986SE
K790845Dualume Laryngeal Examination TelescopeENZ · Traditional 07/24/1979SE

Questions and answers

When was Cool-Lite Fibercoptic Laryngeal Exam cleared by the FDA?

Cool-Lite Fibercoptic Laryngeal Exam (K830888) received a 510(k) decision of Substantially Equivalent on April 27, 1983, 37 days after the submission was received.

What is the product code of K830888?

The FDA product code is EQN – Laryngoscope, Nasopharyngoscope, a Class II (moderate risk) device regulated under 21 CFR 874.4760.