510(k) K001362
K001362 is an FDA 510(k) premarket notification submitted by Karl Storz Imaging, Inc. for the device "KARL STORZ 3D VIDEO SYSTEM". The FDA issued a decision of Substantially Equivalent on July 17, 2000. The device falls under product code GCI (Laryngoscope, Endoscope), a Class II device regulated under 21 CFR 876.1500. Karl Storz Imaging, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2000
- Date Received
- April 28, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laryngoscope, Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type