Video Scope System (Laryngoscope)

FDA 510(k) K944032 · Jedmed Instrument Co.

Substantially Equivalent

510(k) numberK944032

Submission

Device name
Video Scope System (Laryngoscope)
Applicant
Jedmed Instrument Co.
St.Louis, MO, US
Received
August 17, 1994
Decision date
September 15, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
ENZ – Telescope, Laryngeal-Bronchial
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4680
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 ENZ

510(k)DeviceApplicantDecision
K943904Rigid TelescopesENZ · Traditional Karl Storz Endoskop GmbH10/14/1994SE
K790845Dualume Laryngeal Examination TelescopeENZ · Traditional National Medical Technology07/24/1979SE

More from National Medical Technology

510(k)DeviceDecision
K150248ORL Video NasoPharyngo-LarngoscopeEQN · Traditional 07/23/2015SE
K132039Ergo-Flex Laryngo-Nasopharyngoscope Ef-N and Ef-N SlimEQN · Traditional 02/21/2014SE
K021750Lid Chain Eyelid WeightsMML · Traditional 01/27/2003SE
K954184Jed-Light Fiberoptic Light SourceEQH · Traditional 11/13/1995SE
K953457Jedmed Spectrum ENT CabinetETF · Traditional 08/11/1995SE
K950925Jedmed Laryngeal ScopeEOQ · Traditional 08/11/1995SE
K950785Hortmann Airmatic Air Caloric StimulatorKHH · Traditional 06/28/1995SE
K950078Microflow Irrigation SystemKMA · Traditional 06/21/1995SE
K944671Video Scope System (Nasopharyngoscope {Flexible or Rigid})EOB · Traditional 02/07/1995SE
K944031Video Scope System (Otoscope)ERA · Traditional 09/23/1994SE

Questions and answers

When was Video Scope System (Laryngoscope) cleared by the FDA?

Video Scope System (Laryngoscope) (K944032) received a 510(k) decision of Substantially Equivalent on September 15, 1995, 394 days after the submission was received.

What is the product code of K944032?

The FDA product code is ENZ – Telescope, Laryngeal-Bronchial, a Class II (moderate risk) device regulated under 21 CFR 874.4680.