510(k) K993283

OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C by Arnold & Richter Cine Technik — Product Code LLZ

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