Jedmed Compact Endoscopic Beamsplitter
FDA 510(k) K935247 · Jedmed Instrument Co.
510(k) numberK935247
Submission
- Device name
- Jedmed Compact Endoscopic Beamsplitter
- Applicant
- Jedmed Instrument Co.
St.Louis, MO, US - Received
- November 1, 1993
- Decision date
- February 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FEA – Attachment, Teaching, For Endoscope
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FEA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K791635 | Ao Teaching Attachment, Model TA-1FEA · Traditional | American Optical Corp. | 09/24/1979SE |
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| 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 Jedmed Compact Endoscopic Beamsplitter cleared by the FDA?
Jedmed Compact Endoscopic Beamsplitter (K935247) received a 510(k) decision of Substantially Equivalent on February 18, 1994, 109 days after the submission was received.
What is the product code of K935247?
The FDA product code is FEA – Attachment, Teaching, For Endoscope, a Class I (low risk) device regulated under 21 CFR 876.1500.