510(k) K990154
K990154 is an FDA 510(k) premarket notification submitted by Karl Storz Imaging, Inc. for the device "KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM". The FDA issued a decision of Substantially Equivalent on June 1, 1999. The device falls under product code FWF (Camera, Television, Endoscopic, Without Audio), a Class I device regulated under 21 CFR 878.4160. Karl Storz Imaging, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 1999
- Date Received
- January 19, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Television, Endoscopic, Without Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type