Nasal Instruments

FDA 510(k) K820621 · Applied Fiberoptics, Inc.

Substantially Equivalent

510(k) numberK820621

Submission

Device name
Nasal Instruments
Applicant
Applied Fiberoptics, Inc.
Mchenry, IL, US
Received
March 8, 1982
Decision date
March 19, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EQH – Source, Carrier, Fiberoptic Light
Device class
Class I (low risk)
Regulation
21 CFR 874.4350
Specialty
Ear, Nose, Throat

Other 510(k)s with product code EQH

510(k)DeviceApplicantDecision
K945876Weco Endoscopic System with Fiber Optic LightEQH · Traditional Wells Johnson Co.12/04/1995SE
K954184Jed-Light Fiberoptic Light SourceEQH · Traditional Jedmed Instrument Co.11/13/1995SE
K951829Cold Light Source Los 150EQH · Traditional Laser-Optik-Systeme GmbH & Co. KG07/10/1995SE
K932771Battery Powered, Disposable Endoscope Light SourceEQH · Traditional Xomed-Treace, Inc.08/24/1994SE
K941661GM Opti*Cam Camer with Dental Fiber Optic LightEQH · Traditional Gm Engineering, Inc.08/23/1994SE
K941662GM Opti*Cam Camera with ENT Fiber Optic LightEQH · Traditional Gm Engineering, Inc.07/20/1994SE
K934911Saphire Plus Surgical MirrorEQH · Traditional San Diego Swiss Machining, Inc.06/21/1994SE
K932131Mid Labs Twin IlluminatorEQH · Traditional Medical Instrument Development Laboratories, Inc.04/01/1994SE
K930123Aspirating Endo Ocular ProbeEQH · Traditional Surgical Technologies, Inc.02/16/1994SE
K933145Fiberoptic Lightsources and CarriersEQH · Traditional Electro Fiberoptics Corp.09/07/1993SE

More from Electro Fiberoptics Corp.

510(k)DeviceDecision
K964037Flexible CystoscopeFAJ · Traditional 02/20/1997SE
K964482Flexible UreteroscopeFGB · Traditional 01/24/1997SE

Questions and answers

When was Nasal Instruments cleared by the FDA?

Nasal Instruments (K820621) received a 510(k) decision of Substantially Equivalent on March 19, 1982, 11 days after the submission was received.

What is the product code of K820621?

The FDA product code is EQH – Source, Carrier, Fiberoptic Light, a Class I (low risk) device regulated under 21 CFR 874.4350.