FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

RADIOGRAPHIC GRID

K Number: K901012 · Decision Mar 28, 1990
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
14
Applicant Total
6
Review Days
23

Basic Information

Device Name
RADIOGRAPHIC GRID
K Number
K901012
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
892.1910
Medical Specialty
Radiology
Decision
Substantially Equivalent
Applicant
INFAB CORP.
Date Received
March 5, 1990
Decision Date
March 28, 1990
Product Code
IXJ
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
IXJ Grid, Radiographic

Similar 510(k) Clearances

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Other Clearances by INFAB CORP.

K Number Device Name
K900970 RADIATION PROTECTION GLASSES
K900972 RADIATION PROTECTION GLOVES
K901014 RADIOGRAPHIC INTENSIFYING SCREEN
K901013 RADIOGRAPHIC FILM CASSETTE
K896289 RADIATION PROTECTION APRON