Laryngostroboscope
FDA 510(k) K822523 · Kelleher Corp.
510(k) numberK822523
Submission
- Device name
- Laryngostroboscope
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- August 23, 1982
- Decision date
- September 9, 1982
- 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 |
| 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 |
|---|---|---|
| K822618 | Emergency Tracheostomy Instrument SetLJW · Traditional | 01/28/1983SE |
| K822268 | Nagashima Ns-Iii ElectronystagmographGWN · Traditional | 01/28/1983SE |
| K823083 | Electrosurgical UnitGEI · Traditional | 12/07/1982SE |
| K823111 | Nystymograph AccessGNN · Traditional | 11/22/1982SE |
| K822252 | ENT Treatment UnitsETF · Traditional | 11/22/1982SE |
| K822272 | Head Mirrors W/Head Lamps & Head BandsHPQ · Traditional | 11/10/1982SE |
| K822017 | Tympanostomy Tubes & Various TypesETD · Traditional | 10/27/1982SE |
| K822257 | Various Types of Light Source HandlesEOQ · Traditional | 10/26/1982SE |
| K822259 | Laryngeal SpatulasEQH · Traditional | 10/22/1982SE |
| K822004 | Face ShieldsKNT · Traditional | 10/20/1982SE |
Questions and answers
When was Laryngostroboscope cleared by the FDA?
Laryngostroboscope (K822523) received a 510(k) decision of Substantially Equivalent on September 9, 1982, 17 days after the submission was received.
What is the product code of K822523?
The FDA product code is EQL – Laryngostroboscope, a Class I (low risk) device regulated under 21 CFR 874.4750.