510(k) K840837
K840837 is an FDA 510(k) premarket notification submitted by Manico for the device "TBI TRAINER". The FDA issued a decision of Substantially Equivalent on March 25, 1985. The device falls under product code FEJ (Attachment, Binocular, For Endoscope), a Class I device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 1985
- Date Received
- February 24, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Attachment, Binocular, For Endoscope
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type