510(k) K884039
K884039 is an FDA 510(k) premarket notification submitted by Medical Dynamics, Inc. for the device "MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940". The FDA issued a decision of Substantially Equivalent on October 13, 1988. The device falls under product code FWH (Camera, Cine, Surgical, Without Audio), a Class I device regulated under 21 CFR 878.4160. Medical Dynamics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1988
- Date Received
- September 26, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Cine, Surgical, Without Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type