FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C

K Number: K993283 · Decision Dec 29, 1999
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
2
Review Days
90

Basic Information

Device Name
OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C
K Number
K993283
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.2050
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
ARNOLD & RICHTER CINE TECHNIK
Date Received
September 30, 1999
Decision Date
December 29, 1999
Product Code
LLZ
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LLZ System, Image Processing, Radiological

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