Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351
FDA 510(k) K984521 · Richard Wolf Medical Instruments Corp.
510(k) numberK984521
Submission
- Device name
- Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351
- Applicant
- Richard Wolf Medical Instruments Corp.
Vernon Hills, IL, US - Received
- December 21, 1998
- Decision date
- March 17, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351 cleared by the FDA?
Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351 (K984521) received a 510(k) decision of Substantially Equivalent on March 17, 1999, 86 days after the submission was received.
What is the product code of K984521?
The FDA product code is EQL – Laryngostroboscope, a Class I (low risk) device regulated under 21 CFR 874.4750.