510(k) K993283
K993283 is an FDA 510(k) premarket notification submitted by Arnold & Richter Cine Technik for the device "OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C". The FDA issued a decision of Substantially Equivalent on December 29, 1999. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Arnold & Richter Cine Technik has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1999
- Date Received
- September 30, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type