Artus Drill #6000
FDA 510(k) K803288 · Jedmed Instrument Co.
510(k) numberK803288
Submission
- Device name
- Artus Drill #6000
- Applicant
- Jedmed Instrument Co.
Mchenry, IL, US - Received
- December 30, 1980
- Decision date
- January 28, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 510(k) | Device | Decision |
|---|---|---|
| K150248 | ORL Video NasoPharyngo-LarngoscopeEQN · Traditional | 07/23/2015SE |
| K132039 | Ergo-Flex Laryngo-Nasopharyngoscope Ef-N and Ef-N SlimEQN · Traditional | 02/21/2014SE |
| K021750 | Lid Chain Eyelid WeightsMML · Traditional | 01/27/2003SE |
| K954184 | Jed-Light Fiberoptic Light SourceEQH · Traditional | 11/13/1995SE |
| K944032 | Video Scope System (Laryngoscope)ENZ · Traditional | 09/15/1995SE |
| K953457 | Jedmed Spectrum ENT CabinetETF · Traditional | 08/11/1995SE |
| K950925 | Jedmed Laryngeal ScopeEOQ · Traditional | 08/11/1995SE |
| K950785 | Hortmann Airmatic Air Caloric StimulatorKHH · Traditional | 06/28/1995SE |
| K950078 | Microflow Irrigation SystemKMA · Traditional | 06/21/1995SE |
| K944671 | Video Scope System (Nasopharyngoscope {Flexible or Rigid})EOB · Traditional | 02/07/1995SE |
Questions and answers
When was Artus Drill #6000 cleared by the FDA?
Artus Drill #6000 (K803288) received a 510(k) decision of Substantially Equivalent on January 28, 1981, 29 days after the submission was received.
What is the product code of K803288?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.