Pentax Laryngo-Stroboscope Model LS-1A
FDA 510(k) K801866 · Pentax Precision Instrument Corp.
510(k) numberK801866
Submission
- Device name
- Pentax Laryngo-Stroboscope Model LS-1A
- Applicant
- Pentax Precision Instrument Corp.
Mchenry, IL, US - Received
- August 5, 1980
- Decision date
- September 16, 1980
- 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 |
| K884933 | Endostroboscope IVEQL · Traditional | Jedmed Instrument Co. | 02/15/1989SE |
| K842090 | Rhino-Larynx Stroboscope Type 4914EQL · Traditional | Bruel & Kjaer Industri A/S | 07/18/1984SE |
| K822523 | LaryngostroboscopeEQL · Traditional | Kelleher Corp. | 09/09/1982SE |
| K770466 | Stockings, RVS TMEQL · Traditional | Parke-Davis Co. | 03/28/1977SE |
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| K041395 | EG-3630URITX · Traditional | 06/09/2004SE |
| K031789 | EG-3830UT, Video Ultrasound GastroscopeODG · Traditional | 08/08/2003SE |
| K023401 | EG-3830UT, Video Ultrasound GastroscopeODG · Traditional | 02/11/2003SE |
| K023376 | EB-1830T3, Video BronchoscopeEOQ · Special | 10/16/2002SE |
| K021276 | FG-36UX Fiber Ultrasound GastroscopeODG · Traditional | 09/12/2002SE |
| K021278 | EG-3630UR, Ultrasound Video GastroscopeODG · Traditional | 09/06/2002SE |
| K013640 | EG-3630UR, Ultrasund Video GastroscopeFDS · Traditional | 02/04/2002SE |
| K010740 | FG-36UX, Fiber Ultrasound GastroscopeODG · Traditional | 04/17/2001SE |
Questions and answers
When was Pentax Laryngo-Stroboscope Model LS-1A cleared by the FDA?
Pentax Laryngo-Stroboscope Model LS-1A (K801866) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 42 days after the submission was received.
What is the product code of K801866?
The FDA product code is EQL – Laryngostroboscope, a Class I (low risk) device regulated under 21 CFR 874.4750.