510(k) K935247
K935247 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "JEDMED COMPACT ENDOSCOPIC BEAMSPLITTER". The FDA issued a decision of Substantially Equivalent on February 18, 1994. The device falls under product code FEA (Attachment, Teaching, For Endoscope), a Class I device regulated under 21 CFR 876.1500. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1994
- Date Received
- November 1, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Attachment, Teaching, For Endoscope
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type