Endostroboscope IV
FDA 510(k) K884933 · Jedmed Instrument Co.
510(k) numberK884933
Submission
- Device name
- Endostroboscope IV
- Applicant
- Jedmed Instrument Co.
St. Louis, MO, US - Received
- November 28, 1988
- Decision date
- February 15, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EQL – Laryngostroboscope
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4750
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EQL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K984521 | Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351EQL · Traditional | Richard Wolf Medical Instruments Corp. | 03/17/1999SE |
| K921285 | 9105 Rigid Telescopic EndoscopeEQL · Traditional | Kay Elemetrics Corp. | 05/28/1992SE |
| K921184 | RLS 9100 Rhino-Laryngeal StroboscopeEQL · Traditional | Kay Elemetrics Corp. | 05/28/1992SE |
| K842090 | Rhino-Larynx Stroboscope Type 4914EQL · Traditional | Bruel & Kjaer Industri A/S | 07/18/1984SE |
| K822523 | LaryngostroboscopeEQL · Traditional | Kelleher Corp. | 09/09/1982SE |
| K801866 | Pentax Laryngo-Stroboscope Model LS-1AEQL · Traditional | Pentax Precision Instrument Corp. | 09/16/1980SE |
| K770466 | Stockings, RVS TMEQL · Traditional | Parke-Davis Co. | 03/28/1977SE |
More from Parke-Davis Co.
| 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 Endostroboscope IV cleared by the FDA?
Endostroboscope IV (K884933) received a 510(k) decision of Substantially Equivalent on February 15, 1989, 79 days after the submission was received.
What is the product code of K884933?
The FDA product code is EQL – Laryngostroboscope, a Class I (low risk) device regulated under 21 CFR 874.4750.