510(k) K883944
K883944 is an FDA 510(k) premarket notification submitted by Medical Concepts, Inc. for the device "MEC-1 VIDEO COMBO SYSTEM". The FDA issued a decision of Substantially Equivalent on September 28, 1988. The device falls under product code FTS (Camera, Cine, Endoscopic, With Audio), a Class I device regulated under 21 CFR 878.4160. Medical Concepts, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 1988
- Date Received
- September 19, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Cine, Endoscopic, With Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type